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 |