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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K220399
Device Name WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
OTU Medical Inc.
2231 A Fortune Drive
San Jose,  CA  95131
Applicant Contact Geping Liu
93 Springs Rd
Bedford,  MA  01730
Correspondent Contact Mingzi Hussey
Regulation Number874.4680
Classification Product Code
Date Received02/11/2022
Decision Date 06/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No