The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for One Hand Aneroid Sphygmomanometer.
Device ID | K821232 |
510k Number | K821232 |
Device Name: | ONE HAND ANEROID SPHYGMOMANOMETER |
Classification | Blood Pressure Cuff |
Applicant | ABCO DEALERS, INC. 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 | 1982-04-28 |
Decision Date | 1982-05-25 |