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 |