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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 K201300
Device Name Airway Mobilescope
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Olympus Corporation of the America
3500 Corporate Parkway
PO Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact Sheri L. Musgnung
Regulation Number874.4680
Classification Product Code
Date Received05/15/2020
Decision Date 01/26/2021
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
Recalls CDRH Recalls