DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Shenzhen Mindray Bio-Medical Electronics Co., LTD

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-60/dc-60s/dc-60 Exp/dc-55 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK182636
510k NumberK182636
Device Name:DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Medical Electronics Co., LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen,  CN 518057
ContactJiang Haosen
CorrespondentJiang Haosen
Shenzhen Mindray Bio-Medical Electronics Co., LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen,  CN 518057
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-24
Decision Date2019-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904091105 K182636 000
06936415925703 K182636 000
06936415925710 K182636 000
06936415925741 K182636 000
06936415925758 K182636 000
06936415977818 K182636 000
06936415977825 K182636 000
06936415977832 K182636 000
06936415977849 K182636 000
06936415977856 K182636 000
06936415912499 K182636 000

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