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 |
50096295143855 | K202757 | 000 |