OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS

System, Imaging, Pulsed Doppler, Ultrasonic

CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC

The following data is part of a premarket notification filed by Chang Gung Medical Technology Co., Ltd. Linkou Fac with the FDA for Opus Diagnostic Ultrasound System & Transducers.

Pre-market Notification Details

Device IDK102989
510k NumberK102989
Device Name:OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC 7263 CRONIN CIRCLE Dublin,  CA  94568
ContactBob Leiker
CorrespondentBob Leiker
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC 7263 CRONIN CIRCLE Dublin,  CA  94568
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-06
Decision Date2010-12-09
Summary:summary

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