Norav 1200 Series PC-ECG
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG,…
Norav 1200 Series PC-ECG Software Kit with the following Option(s): – S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) – S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools – I3 = Resting-ECG Measurement and Interpretation MEANS (Uni. of Rotterdam, NL) – D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key – “HASP-Key” Software on Installation Medium (CD or USB-Stick).
17manufacturers in China registered for this device type
154catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (10), Beijing (2), Jiangsu (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Armorlink SH Corp | Shanghai | Shanghai | Contract manufacturer | 2 |
| Tontec Precision Plastics Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
Showing 12 of 17. All 17 manufacturers in China registered for Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Record
| Listed by | Norav Medical Inc., United States |
|---|---|
| FDA product code | MWI |
| Device type | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K000404 |
| Record published | 2020-07-09 |
| Record revised | 2020-04-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1200W Kit | In distribution | |
| ECGUSB1DEXR Kit | In distribution | |
| SW L1 | In distribution | |
| ECGUSB1DEX Kit | In distribution | |
| 1200M Kit | In distribution | |
| SW I2 | In distribution | |
| 1200HRT | In distribution | |
| 1200T Kit | In distribution | |
| ECGUSB1DEX | In distribution | |
| 1200W1 | In distribution | |
| 1200W Kit | In distribution | |
| 1200HR | In distribution | |
| 1200HR | In distribution | |
| SW NEMS-Q1 | In distribution | |
| 1200HR Kit | In distribution | |
| 1200T | In distribution | |
| 1200T | In distribution | |
| 1200T | In distribution | |
| 1200W Kit | In distribution | |
| 1200T | In distribution | |
| ECGUSB1A | In distribution | |
| 1200HR | In distribution | |
| ECGUSB1DEXR | In distribution | |
| 1200HRT | In distribution | |
| 1200S Kit | In distribution | |
| 1200S Kit | In distribution | |
| SW NEMS-Q 10 | In distribution | |
| SW H1 | In distribution | |
| 1200T | In distribution | |
| 1200T Kit | In distribution | |
| 1200HR Kit | In distribution | |
| 1200HR Kit | In distribution | |
| 1200W2 | In distribution | |
| 1200W2 | In distribution | |
| 1200W Kit | In distribution | |
| 1200WR | In distribution | |
| 1200HRT | In distribution | |
| 1200HRT Kit | In distribution | |
| 1200W2 | In distribution | |
| SW NEMS-A1 | In distribution | |
| ECGUSB1DEX | In distribution | |
| 1200HRT Kit | In distribution | |
| 1200HRT | In distribution | |
| 1200W Kit | In distribution | |
| 1200W Kit | In distribution | |
| 1200W Kit | In distribution | |
| BlueECG Kit | In distribution | |
| ECGLAN Green PC | In distribution | |
| 1200HRT Kit | In distribution | |
| 1200HR Kit | In distribution | |
| 1200M Kit | In distribution | |
| 1200T | In distribution | |
| 1200M Kit | In distribution | |
| ECGUSB1DEX | In distribution | |
| 1200W2 | In distribution | |
| 1200HRT | In distribution | |
| 1200W Kit | In distribution | |
| ECGUSB1DEX Kit | In distribution | |
| ECGUSB1DEX | In distribution | |
| 1200M Kit | In distribution | |
| 1200W Kit | In distribution | |
| 1200HR Kit | In distribution | |
| SW S2 | In distribution | |
| 1200S | In distribution | |
| 1200W2 | In distribution | |
| 1200T | In distribution | |
| 1200W2 | In distribution | |
| 1200HR | In distribution | |
| 1200HRT | In distribution | |
| 1200W1 | In distribution | |
| SW S1 | In distribution | |
| 1200HR | In distribution | |
| SW S2-I2 | In distribution | |
| 1200M Kit | In distribution | |
| SW NEMS-Q 250 | In distribution | |
| SW S2toS2 | In distribution | |
| ECGUSB1A Kit | In distribution | |
| SW S2-I2-D1 | In distribution | |
| 1200HRT Kit | In distribution | |
| 1200W2 | In distribution | |
| 1200WR | In distribution | |
| 1200T | In distribution | |
| 1200T Kit | In distribution | |
| 1200W2 | In distribution | |
| 1200M Kit | In distribution | |
| 1200M Kit | In distribution | |
| 1200W Kit | In distribution | |
| 1200W2 | In distribution | |
| ECGUSB1DEX Kit | In distribution | |
| 1200W Kit | In distribution | |
| 1200S | In distribution | |
| 1200W2 | In distribution | |
| 1200W Kit | In distribution | |
| 1200W2 | In distribution | |
| ECGUSB1DEXR Kit | In distribution | |
| SW NER | In distribution | |
| SW I3-N | In distribution | |
| 1200M Kit | In distribution | |
| 1200S | In distribution | |
| 1200HRT | In distribution | |
| SW P-MP200 | In distribution | |
| BlueECG | In distribution | |
| 1200W Kit | In distribution | |
| 1200W2 | In distribution | |
| ECGUSB1DEX Kit | In distribution | |
| SW I3 | In distribution | |
| 1200W2 | In distribution | |
| 1200HRT Kit | In distribution | |
| ECGUSB1DEXR | In distribution | |
| ECGUSB1DEX Kit | In distribution | |
| 1200T Kit | In distribution | |
| 1200T Kit | In distribution | |
| 1200HR | In distribution | |
| 1200W2 | In distribution | |
| 1200T Kit | In distribution | |
| 1200HRT Kit | In distribution | |
| 1200HRT | In distribution | |
| ECGUSB1DEX Kit | In distribution | |
| 1200S Kit | In distribution | |
| ECGUSB1DEXR Kit | In distribution | |
| 1200S Kit | In distribution | |
| 1200W Kit | In distribution | |
| ECGUSB1DEX | In distribution | |
| SW NEMS-Q 50 | In distribution | |
| 1200HRT Kit | In distribution | |
| SW NHL7 | In distribution | |
| 1200T Kit | In distribution | |
| 1200M Kit | In distribution | |
| SW S2-I3-D1 | In distribution | |
| SW NEMS-A2 | In distribution | |
| 1200W Kit | In distribution | |
| 1200T | In distribution | |
| 1200M | In distribution | |
| ECGUSB1DEXR | In distribution | |
| 1200HRT | In distribution | |
| 1200W Kit | In distribution | |
| SW NEMS-CL | In distribution | |
| 1200W Kit | In distribution | |
| ECGUSB1DEXR | In distribution | |
| 1200HR Kit | In distribution | |
| 1200HR Kit | In distribution | |
| 1200W Kit | In distribution | |
| 1200M Kit | In distribution | |
| ECGUSB1DEX Kit | In distribution | |
| SW NH300 DL-Rv to 301 | In distribution | |
| 1200W Kit | In distribution | |
| SW M1 | In distribution | |
| 1200W1 | In distribution | |
| SW S2-I1-D1 | In distribution | |
| SW S2-I1 | In distribution | |
| 1200T Kit | In distribution | |
| SW I1 | In distribution | |
| ECGUSB1DEX | In distribution | |
| 1200T Kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 501 |
| SmartLinx Vitals Plus | Philips North America LLC | 174 |
| Capsule Vitals Plus | Philips North America LLC | 64 |
| Iradimed | Iradimed Corporation | 59 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | GE Medical Systems Information Technologies, Inc. | 44 |
| Medrad® Veris™ 8600 Vital Signs Monitor | Bayer Medical Care Inc. | 26 |
| Xper Flex Cardio Physiomonitoring System | Philips DS North America LLC | 24 |
| Wvsm Wireless Vital Signs Monitor | Athena GTX | 23 |
| 740 Select | ZOE Medical, Inc. | 20 |
| Wvsm Pro, Wireless Vital Signs Monitor Professional | Athena GTX | 20 |
| BioStamp nPoint™ | Medidata Solutions, Inc. | 19 |
| BioStamp nPoint™ | Mc10, Inc. | 18 |
Showing 12 of 314. All products under Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110463 | 2011-11-10 |
| K080141 | 2008-04-25 |
| K000404 | 2000-11-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.