MEDISON 4800

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 4800.

Pre-market Notification Details

Device IDK925582
510k NumberK925582
Device Name:MEDISON 4800
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON AMERICA, INC. 5319 RANDALL PL. Fremont,  CA  94538
ContactMark F Hayward
CorrespondentMark F Hayward
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 Received1992-11-05
Decision Date1994-12-27

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