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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 K900555
Device Name INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.
Applicant
Interson Corp.
7068 Koll Center Pkwy., #415
Pleasanton,  CA  94566
Applicant Contact MARK F HAYWARD
Correspondent
Interson Corp.
7068 Koll Center Pkwy., #415
Pleasanton,  CA  94566
Correspondent Contact MARK F HAYWARD
Regulation Number892.1570
Classification Product Code
ITX  
Date Received02/06/1990
Decision Date 05/02/1990
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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