The following data is part of a premarket notification filed by Pinhu Sama Medical Packing Co., Ltd. with the FDA for Disposable Blood Pressure Cuff Guard.
| Device ID | K150227 |
| 510k Number | K150227 |
| Device Name: | Disposable Blood Pressure Cuff Guard |
| Classification | Blood Pressure Cuff |
| Applicant | PINHU SAMA MEDICAL PACKING CO., LTD. 1 QUNFENG ROAD, SOUTH OF LINDAI Pinghu, CN 214202 |
| Contact | Ma Jianzhong |
| Correspondent | Ray Wang BEIJING BELIEVE TECH. SERVICE CO., LTD. 1-202, BUILD 3, BEIJING NEW WORLD NO.5 CHAOGYANG RD., CHAOGYANG DISTRICT Beijing, CN 100024 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884389100527 | K150227 | 000 |
| 30884389100473 | K150227 | 000 |
| 30884389100442 | K150227 | 000 |