MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

MEDISON CO., LTD.

The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Mysono U5 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK100186
510k NumberK100186
Device Name:MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON CO., LTD. 1394 25TH STREET NW Buffalo,  MN  55313
ContactMark Job
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-01-22
Decision Date2010-03-24
Summary:summary

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