LD-Oxy
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It…
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
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 | LD Technology LLC, 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 | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K160956 |
| Record published | 2019-01-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D001 | 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 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 154 |
| 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 |
Showing 12 of 314. All products under Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200141 | 2020-04-27 |
| K160956 | 2016-07-06 |
| K130056 | 2013-04-11 |
| K083229 | 2009-02-23 |
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.