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 |