The following data is part of a premarket notification filed by Pinghu Sama Medical Packing Co., Ltd. with the FDA for Sama Disposable Blood Pressure Cuff Barriers.
| Device ID | K141998 |
| 510k Number | K141998 |
| Device Name: | SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS |
| Classification | Blood Pressure Cuff |
| Applicant | PINGHU SAMA MEDICAL PACKING CO., LTD. 853 DORCHESTER LN, UNIT-B New Milford, NJ 07646 |
| Contact | Charles Shen |
| Correspondent | Charles Shen PINGHU SAMA MEDICAL PACKING CO., LTD. 853 DORCHESTER LN, UNIT-B New Milford, NJ 07646 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-23 |
| Decision Date | 2014-09-19 |
| Summary: | summary |