The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A&d Automatic Digital Blood Pressure Meter 2650.
Device ID | K895429 |
510k Number | K895429 |
Device Name: | A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
Contact | Kimio Shibata |
Correspondent | Kimio Shibata A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-05 |
Decision Date | 1989-11-28 |