CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE

System, Imaging, Pulsed Doppler, Ultrasonic

CHISON MEDICAL IMAGING CO., LTD.

The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Chison Diagnostic Ultrasound System,convex Probe,linear Probe,transvaginal Micro-convex Probe.

Pre-market Notification Details

Device IDK113359
510k NumberK113359
Device Name:CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant CHISON MEDICAL IMAGING CO., LTD. 7263 CRONIN CIRCLE Dublin,  CA  94568
ContactBob Leiker
CorrespondentBob Leiker
CHISON MEDICAL IMAGING CO., LTD. 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 Received2011-11-14
Decision Date2012-02-03
Summary:summary

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