The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for Digital Sphygmomanometer Model Ub-211 And 212.
| Device ID | K912119 |
| 510k Number | K912119 |
| Device Name: | DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
| Contact | Albert J Pinza |
| Correspondent | Albert J Pinza 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 | 1991-05-14 |
| Decision Date | 1991-08-07 |