The following data is part of a premarket notification filed by Avita Corporation with the FDA for Arm Type Blood Pressure Monitor.
| Device ID | K180155 |
| 510k Number | K180155 |
| Device Name: | Arm Type Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Avita Corporation 9F, No.78, Sec. 1, Kwang-Fu Road. San-Chung District Taiwan, TW 24158 |
| Contact | Steven Jhou |
| Correspondent | Anita Chen ZhengCheng Consulting Company NO.19, 335 Lane, Fu-Xi Rd, Shulin Dist., New Taipei City New Taipei, TW 238 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-08-03 |
| Summary: | summary |