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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 K182253
Device Name FUJIFILM Video Bronchoscopes
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
FUJIFILM Medical Systems U.S.A, Inc.
10 High Point Drive
Wayne,  NJ  07470
Correspondent Contact Jeffrey Wan
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received08/20/2018
Decision Date 04/04/2019
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
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