WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

Bronchoscope (flexible Or Rigid)

OTU Medical Inc.

The following data is part of a premarket notification filed by Otu Medical Inc. with the FDA for Wiscope Digital Bronchoscope System, Wiscope Single-use Digital Flexible Bronchoscope, Wiscope Image System.

Pre-market Notification Details

Device IDK220399
510k NumberK220399
Device Name:WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
ClassificationBronchoscope (flexible Or Rigid)
Applicant OTU Medical Inc. 2231 A Fortune Drive San Jose,  CA  95131
ContactGeping Liu
CorrespondentMingzi Hussey
Zi-medical 93 Springs Rd Bedford,  MA  01730
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-11
Decision Date2022-06-16

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