The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Contec08a Electronic Sphygmomanometer, Contec08c Electronic Sphygmomanometer, Abpm50 Automatic Blood Pressure Monitor.
| Device ID | K202757 |
| 510k Number | K202757 |
| Device Name: | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Contec Medical Systems Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone Hebei Province, CN 066004 |
| Contact | Xueyong Li |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, CN 102401 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2021-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040106234 | K202757 | 000 |
| 06945040106296 | K202757 | 000 |
| 06945040106289 | K202757 | 000 |
| 06945040106272 | K202757 | 000 |