The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Aneroid Sphymomanometer.
Device ID | K792355 |
510k Number | K792355 |
Device Name: | ANEROID SPHYMOMANOMETER |
Classification | Blood Pressure Cuff |
Applicant | ABCO DEALERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-21 |
Decision Date | 1979-12-05 |