SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS

System, Imaging, Pulsed Doppler, Ultrasonic

MEDISON AMERICA, INC.

The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Sonoace 6000c Diagnostic Ultrasound System And Transducers, Also Called Ultrasound System And Transducers.

Pre-market Notification Details

Device IDK990970
510k NumberK990970
Device Name:SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
ContactBob Leiker
CorrespondentCarole Stamp
TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-03-23
Decision Date1999-04-07
Summary:summary

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