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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 K940942
Device Name COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER
Applicant
Medison America, Inc.
5880 W. Las Positas Blvd.,
Suite 52
Pleasanton,  CA  94566
Applicant Contact MARK F HAYWARD
Correspondent
Medison America, Inc.
5880 W. Las Positas Blvd.,
Suite 52
Pleasanton,  CA  94566
Correspondent Contact MARK F HAYWARD
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received03/01/1994
Decision Date 02/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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