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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K872027
Device Name OLYMPUS GF-UM2/EU-M2
Applicant
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Applicant Contact BARLOW, PH.D.
Correspondent
Olympus Corp.
4 Nevada Dr.
Lake Success,  NY  11042
Correspondent Contact BARLOW, PH.D.
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/26/1987
Decision Date 08/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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