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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 K924432
Device Name MEDISON 1500
Applicant
Medison Co., Ltd.
5319 Randall Pl.
Fremont,  CA  94538
Applicant Contact GARY J ALLSEBROOK
Correspondent
Medison Co., Ltd.
5319 Randall Pl.
Fremont,  CA  94538
Correspondent Contact GARY J ALLSEBROOK
Regulation Number892.1560
Classification Product Code
IYO  
Date Received09/01/1992
Decision Date 11/24/1993
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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