Medical Device Manufacturer · US , Great Neck , NY

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. - FDA 510(k) Clear...

9 submissions · 9 cleared · Since 2012

Recent clearances: VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor, ViewMate Multi Ultrasound System, Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Dec 15, 2022

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

Cardiovascular · 227d

Cleared Aug 02, 2017

Accutorr 7/VS-900 Vital Signs Monitor

Cardiovascular · 146d

Cleared Dec 22, 2014

Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)

Cardiovascular · 46d

Cleared Jul 01, 2014

HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM,...

Cardiovascular · 365d