COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER

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 Combison 530 Diagnostic Ultrasound Scanner.

Pre-market Notification Details

Device IDK940942
510k NumberK940942
Device Name:COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON AMERICA, INC. 5880 WEST LAS POSITAS BLVD., SUITE 52 Pleasanton,  CA  94566
ContactMark F Hayward
CorrespondentMark F Hayward
MEDISON AMERICA, INC. 5880 WEST LAS POSITAS BLVD., SUITE 52 Pleasanton,  CA  94566
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-01
Decision Date1997-02-19
Summary:summary

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