The following data is part of a premarket notification filed by Caremate Medical Device Co., Ltd with the FDA for Caremate Sphygmomanometer With Stethoscope.
Device ID | K090014 |
510k Number | K090014 |
Device Name: | CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE |
Classification | Blood Pressure Cuff |
Applicant | CAREMATE MEDICAL DEVICE CO., LTD SUITE 8D, NO. 19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
Contact | Xiaoming Hong |
Correspondent | Xiaoming Hong CAREMATE MEDICAL DEVICE CO., LTD SUITE 8D, NO. 19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-01-02 |
Decision Date | 2009-04-09 |
Summary: | summary |