The following data is part of a premarket notification filed by Unimed Medical Supplies Inc. with the FDA for Unimed Disposable Blood Pressure Cuff.
Device ID | K120364 |
510k Number | K120364 |
Device Name: | UNIMED DISPOSABLE BLOOD PRESSURE CUFF |
Classification | Blood Pressure Cuff |
Applicant | UNIMED MEDICAL SUPPLIES INC. NO.37, YANSHAN ROAD, SHEKOU Shenzhen, Guangdong, CN 518067 |
Contact | Xinmei Tan |
Correspondent | Xinmei Tan UNIMED MEDICAL SUPPLIES INC. NO.37, YANSHAN ROAD, SHEKOU Shenzhen, Guangdong, CN 518067 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-06 |
Decision Date | 2012-05-04 |
Summary: | summary |