SA6000II 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 Sa6000ii Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK012887
510k NumberK012887
Device Name:SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON AMERICA, INC. 16303 PANORAMIC WAY San Leandro,  CA  94578 -1116
ContactGary J Allsebrook
CorrespondentMark Job
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 Received2001-08-28
Decision Date2001-09-12
Summary:summary

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