SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM

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 Sonoace 5500 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK992761
510k NumberK992761
Device Name:SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton,  CA  94588
ContactMoon T Kwon
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received1999-08-17
Decision Date1999-09-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.