The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Arm Type Blood Pressure Monitor.
| Device ID | K112825 |
| 510k Number | K112825 |
| Device Name: | AVITA ARM TYPE BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | AVITA CORPORATION 2904 N. BOLDT DR. Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich AVITA CORPORATION 2904 N. BOLDT DR. Flagstaff, AZ 86001 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2012-01-18 |