The following data is part of a premarket notification filed by A&d Company, Ltd with the FDA for A&d Medical Um-212ble Blood Pressure Monitor.
| Device ID | K212168 |
| 510k Number | K212168 |
| Device Name: | A&D Medical UM-212BLE Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | A&D Company, Ltd 1756 Automation Parkway San Jose, CA 95131 |
| Contact | Chanda Melville |
| Correspondent | Chanda Melville A&D Company, Ltd 1756 Automation Parkway San Jose, CA 95131 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2022-10-06 |