Wrist Type Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Avita Corporation

The following data is part of a premarket notification filed by Avita Corporation with the FDA for Wrist Type Blood Pressure Monitor.

Pre-market Notification Details

Device IDK200346
510k NumberK200346
Device Name:Wrist Type Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Avita Corporation 9F, No.78, Sec. 1, Kwang-Fu Road, San-Chung District New Taipei City,  TW 24158
ContactAmber Dong
CorrespondentAnita Chen
ZhengCheng Consulting Corporation 238, No.19, 335 Lane, Fu-Xi Road, Shulin District New Taipei City New Taipei City,  TW 238
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-11
Decision Date2020-12-17

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