COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION

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 530d/voluson 530d, Tissue Harmonic Imaging (thi) Option.

Pre-market Notification Details

Device IDK993517
510k NumberK993517
Device Name:COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
ContactGary J Allsebrook
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-10-18
Decision Date1999-11-02
Summary:summary

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