The following data is part of a premarket notification filed by David Cott Co. with the FDA for Blood Pressure Cuff Cover.
Device ID | K781671 |
510k Number | K781671 |
Device Name: | BLOOD PRESSURE CUFF COVER |
Classification | Blood Pressure Cuff |
Applicant | DAVID COTT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-03 |
Decision Date | 1978-11-16 |