The following data is part of a premarket notification filed by Statcorp, Inc. with the FDA for Ultracuff Blood Pressure Cuff And Inflation Bag.
| Device ID | K954282 |
| 510k Number | K954282 |
| Device Name: | ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG |
| Classification | Blood Pressure Cuff |
| Applicant | STATCORP, INC. 1200 COLUMBIA AVE. P.O. BOX 1225 Franklin, TN 37065 |
| Contact | James M Shepherd |
| Correspondent | James M Shepherd STATCORP, INC. 1200 COLUMBIA AVE. P.O. BOX 1225 Franklin, TN 37065 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-13 |
| Decision Date | 1996-02-06 |