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 |