Cardiovit CS-200 Excellence
The CARDIOVIT CS-200 Excellence is a multichannel ECG device used for the recording, analysis and evaluation of ECG recordings. It is designed for indoor use and can be used for all…
The CARDIOVIT CS-200 Excellence is a multichannel ECG device used for the recording, analysis and evaluation of ECG recordings. It is designed for indoor use and can be used for all patients of both sexes, all races, and all ages and is intended for use in hospitals, cardiologic units, out-patient clinical units, and general physicians offices.The diagnostic applications for which the CARDIOVIT CS-200 Excellence is intended is in the field of cardiac abnormalities in the general population, detecting acute myocardial ischemia, and infarction in chest pain patients.
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (2), Beijing (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 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| 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 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph
Record
| Listed by | Schiller AG, Switzerland |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| Establishment | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K970879 |
| Record published | 2023-06-06 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature 5 to 50 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.920280 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,734 |
| M Series Biphasic | Zoll Medical Corporation | 93 |
| ELI 380 | Mortara Instrument, Inc. | 69 |
| Patient Cable Lead Set | Mortara Instrument, Inc. | 56 |
| ELI 250c | Mortara Instrument, Inc. | 50 |
| Lutech | Lutech Industries | 49 |
| ELI 150c | Mortara Instrument, Inc. | 47 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 41 |
| ELI 280 | Mortara Instrument, Inc. | 41 |
| Electrocardiograph | Edan Instruments, Inc. | 38 |
| Q-Stress | Mortara Instrument, Inc. | 25 |
| XScribe | Mortara Instrument, Inc. | 22 |
Showing 12 of 177. All products under Electrocardiograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183425 | 2020-03-02 |
| K170182 | 2017-07-19 |
| K152043 | 2016-05-06 |
| K050686 | 2005-05-04 |
| K031557 | 2004-04-14 |
| K864465 | 1987-03-20 |
| K850702 | 1985-04-25 |
| K841254 | 1985-01-24 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-07-24 | Class II | Software design | Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs. | 1084 untis |
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.