The following data is part of a premarket notification filed by Shenzhen Caremed Medical Technology Co., Ltd. with the FDA for Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff.
| Device ID | K182433 |
| 510k Number | K182433 |
| Device Name: | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff |
| Classification | Blood Pressure Cuff |
| Applicant | Shenzhen Caremed Medical Technology Co., Ltd. East Side, 3/F, C Building, Kelunte Low-Carbon Industries Gaofeng Community Dalang Office, Longhua District, Shenzhe, CN 518109 |
| Contact | Alan Xie |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, Nanshan Medical Devices Industrial Park Nanshan District Shenzhen, CN 518067 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-06 |
| Decision Date | 2018-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970758507820 | K182433 | 000 |
| 06970758507806 | K182433 | 000 |