The following data is part of a premarket notification filed by Statcorp, Inc. with the FDA for Statcorp Inc. Disposable Blood Pressure Cuff.
Device ID | K940214 |
510k Number | K940214 |
Device Name: | STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFF |
Classification | Blood Pressure Cuff |
Applicant | STATCORP, INC. P.O. BOX 1225 1200 COLUMBIA HIGHWAY Franklin, TN 37065 |
Contact | James M Shepherd |
Correspondent | James M Shepherd STATCORP, INC. P.O. BOX 1225 1200 COLUMBIA HIGHWAY 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 | 1994-01-14 |
Decision Date | 1994-02-22 |