The following data is part of a premarket notification filed by Shanghai Medifriend Medical Products Co., Ltd. with the FDA for Medifriend Professional Sphygmomanometer.
| Device ID | K950778 |
| 510k Number | K950778 |
| Device Name: | MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER |
| Classification | Blood Pressure Cuff |
| Applicant | SHANGHAI MEDIFRIEND MEDICAL PRODUCTS CO., LTD. 850, WU ZHONG ROAD Shanghai, CN 201103 |
| Contact | Aden Ting |
| Correspondent | Aden Ting SHANGHAI MEDIFRIEND MEDICAL PRODUCTS CO., LTD. 850, WU ZHONG ROAD Shanghai, CN 201103 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-03-14 |