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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound Bronchoscope
510(k) Number K183525
Device Name EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Olympus Corporation of the Americas
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact Sheri Musgnung
Regulation Number892.1550
Classification Product Code
PSV  
Subsequent Product Codes
ITX   IYN  
Date Received12/19/2018
Decision Date 09/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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