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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 doppler, ultrasonic
510(k) Number K974269
Device Name SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,
Applicant
MEDISON AMERICA, INC.
6616 OWENS DR.
PLEASANTON,  CA  94588
Applicant Contact PETER KLEIN
Correspondent
MEDISON AMERICA, INC.
6616 OWENS DR.
PLEASANTON,  CA  94588
Correspondent Contact PETER KLEIN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received11/13/1997
Decision Date 08/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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