The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A&d Medical Lifesource Digital Blood Pressure Monitors, Models Ub-511 & Ub-512.
| Device ID | K042967 |
| 510k Number | K042967 |
| Device Name: | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | A & D ENGINEERING, INC. 1555 MCCANDLESS DR. Milpitas, CA 95035 |
| Contact | Jerry Wang |
| Correspondent | Jerry Wang A & D ENGINEERING, INC. 1555 MCCANDLESS DR. Milpitas, CA 95035 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-28 |
| Decision Date | 2004-12-03 |
| Summary: | summary |