SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM

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 Sa 9900 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK002185
510k NumberK002185
Device Name:SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON AMERICA, INC. 16303 PANORAMIC WAY San Leandro,  CA  94578 -1116
ContactGary J Allsebrook
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 Received2000-07-19
Decision Date2000-08-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.