NAVIRFA Scope

System, Imaging, Pulsed Echo, Ultrasonic

NaviFUS Corporation

The following data is part of a premarket notification filed by Navifus Corporation with the FDA for Navirfa Scope.

Pre-market Notification Details

Device IDK211529
510k NumberK211529
Device Name:NAVIRFA Scope
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant NaviFUS Corporation 12F., No. 246, Sec. 3, Chengde Rd. Datong Dist., Taipei City,  TW 10367
ContactArthur Lung
CorrespondentArthur Lung
NaviFUS Corporation 12F., No. 246, Sec. 3, Chengde Rd. Datong Dist., Taipei City,  TW 10367
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-17
Decision Date2022-05-05

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