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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K001203
Device Name OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT
Applicant
The Olympus Optical Co.
Two Corporate Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
The Olympus Optical Co.
Two Corporate Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/13/2000
Decision Date 05/26/2000
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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