MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM

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 Medison 88p Diagnostic Ultrasound Imaging Sytem.

Pre-market Notification Details

Device IDK930579
510k NumberK930579
Device Name:MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON AMERICA, INC. 5319 RANDALL PL. Fremont,  CA  94538
ContactGary Allsebrook
CorrespondentGary Allsebrook
MEDISON AMERICA, INC. 5319 RANDALL PL. Fremont,  CA  94538
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-04
Decision Date1993-11-03

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