SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

MEDISON AMERICA, INC.

The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Sonoace 600 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK000030
510k NumberK000030
Device Name:SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
ContactGary J Allesbrook
CorrespondentCarole Stamp
TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2000-01-05
Decision Date2000-01-19

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