SA8800 DIAGNOSTIC 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 Sa8800 Diagnostic Ultrasound System And Transducers,.

Pre-market Notification Details

Device IDK974269
510k NumberK974269
Device Name:SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
ContactPeter Klein
CorrespondentPeter Klein
MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-13
Decision Date1998-08-21
Summary:summary

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