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 2510/20.
| Device ID | K895428 |
| 510k Number | K895428 |
| Device Name: | A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20 |
| 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 |