The following data is part of a premarket notification filed by Pa Medical Corp. with the FDA for Inflate-a-cuff #7014.
Device ID | K910903 |
510k Number | K910903 |
Device Name: | INFLATE-A-CUFF #7014 |
Classification | Blood Pressure Cuff |
Applicant | PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
Contact | Bailey Vaughn |
Correspondent | Bailey Vaughn PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-05 |
Decision Date | 1991-05-08 |