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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 K021204
Device Name OLYMPUS BF TYPE UM40
Applicant
Olympus Optical Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DERWYN REUBER
Regulation Number892.1550
Classification Product Code
PSV  
Subsequent Product Codes
ITX   ODG  
Date Received04/16/2002
Decision Date 05/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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