The following data is part of a premarket notification filed by Suzhou Minhua Medical Apparatus with the FDA for Minhua Disposable Blood Pressure Cuff.
Device ID | K143728 |
510k Number | K143728 |
Device Name: | Minhua Disposable Blood Pressure Cuff |
Classification | Blood Pressure Cuff |
Applicant | SUZHOU MINHUA MEDICAL APPARATUS You Yi Industrial Park Songlin Town, CN 215222 |
Contact | Ji Dong Yang |
Correspondent | Rhonda Alexander Registrar Corp Medical Device Division 144 Research Drive Hampton, VA 23666 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-29 |
Decision Date | 2015-05-15 |
Summary: | summary |