The following data is part of a premarket notification filed by Unimed Medical Supplies Inc. with the FDA for Unimed Blood Pressure Cuff.
Device ID | K112544 |
510k Number | K112544 |
Device Name: | UNIMED 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 | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-09-01 |
Decision Date | 2011-11-22 |
Summary: | summary |