The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Bpm6 Series Blood Pressure Meter (or Monitor), Model Bpm6xy.
| Device ID | K033397 |
| 510k Number | K033397 |
| Device Name: | AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | AVITA CORPORATION 9F, NO. 78, SEC. 1, KWANG-FU RD. San-chung, Taipei County, TW 241 |
| Contact | Geo Lin |
| Correspondent | Geo Lin AVITA CORPORATION 9F, NO. 78, SEC. 1, KWANG-FU RD. San-chung, Taipei County, TW 241 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-24 |
| Decision Date | 2004-04-09 |
| Summary: | summary |