CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND 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, Phased And Convex Probe, Pencil And Convex Probe.

Pre-market Notification Details

Device IDK140364
510k NumberK140364
Device Name:CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND 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 Received2014-02-12
Decision Date2014-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945121406642 K140364 000
06945121406635 K140364 000
06945121406628 K140364 000
06945121406611 K140364 000
06945121406598 K140364 000
06945121406581 K140364 000
06945121407304 K140364 000
06945121407083 K140364 000
06945121406864 K140364 000

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