The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A&d Tm-2421/2021 Ambulatory Blood Pressure Monitor.
Device ID | K914273 |
510k Number | K914273 |
Device Name: | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR |
Classification | Computer, Blood-pressure |
Applicant | A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
Contact | Albert J Pinza |
Correspondent | Albert J Pinza A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
Product Code | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-24 |
Decision Date | 1993-02-09 |