The following data is part of a premarket notification filed by Avita Corporation with the FDA for Wrist Type Blood Pressure Monitor.
Device ID | K200346 |
510k Number | K200346 |
Device Name: | Wrist 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 New Taipei City, TW 24158 |
Contact | Amber Dong |
Correspondent | Anita Chen ZhengCheng Consulting Corporation 238, No.19, 335 Lane, Fu-Xi Road, Shulin District New Taipei City New Taipei City, 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 | 2020-02-11 |
Decision Date | 2020-12-17 |