The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A&d Medical Lifesource Ub-401pc & Ub-401 Digital Blood Pressure Monitors.
| Device ID | K002115 |
| 510k Number | K002115 |
| Device Name: | A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS |
| 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 | 2000-07-13 |
| Decision Date | 2000-07-25 |