Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

FDA Regulatory Profile

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. has 0 FDA recalls, 0 inspections, 9 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Dec 15, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances9Oct 4, 2026Not statedCurrent
Inspections0Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K221267VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs MonitorDec 15, 2022
K222754ViewMate Multi Ultrasound SystemNov 9, 2022
K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa…Apr 8, 2021
K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemDec 13, 2017
K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemSep 12, 2017
K170712Accutorr 7/VS-900 Vital Signs MonitorAug 2, 2017
K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Dec 22, 2014
K132036HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)Jul 1, 2014
K113632DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMJan 25, 2012