DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 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-90/dc-90s/dc-90q/dc-95/dc-95s/dc-88/dc-88s/dc-80a/dc-80aexp/dc-80a Pro/dc-8x/dc-8q/dc-81/dc-82 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK201693
510k NumberK201693
Device Name:DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South Hi-tech Industrial Park Nanshan,  CN 518057
ContactZhang Wei
CorrespondentZhang Wei
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South Hi-tech Industrial Park Nanshan,  CN 518057
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeLLZ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-22
Decision Date2020-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06936415972622 K201693 000
06936415925628 K201693 000
06936415925635 K201693 000
06936415925642 K201693 000
06936415925659 K201693 000
06936415925666 K201693 000
06936415925673 K201693 000
06936415927332 K201693 000
06936415972516 K201693 000
06936415972561 K201693 000
06936415972585 K201693 000
06936415910389 K201693 000

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