The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for Digital Blood Pressure Monitors, Models Tm-2655, Tm-2655p, & Tm-2655vp.
| Device ID | K010828 |
| 510k Number | K010828 |
| Device Name: | DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
| Contact | Jerry Wang |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-03-20 |
| Decision Date | 2001-03-29 |