Medical Device Manufacturer · CN , Shenzhen

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

158 submissions · 158 cleared · Since 2004

Recent clearances: ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Diagnostic Ultrasound System (MU9), uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

Official Website

158

Total

158

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Jun 09, 2016

BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M...

Chemistry · 120d

Cleared Sep 02, 2014

BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER

Chemistry · 167d

Cleared Mar 23, 2012

BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER

Chemistry · 219d

Cleared Feb 01, 2008

BS-200 CHEMISTRY ANALYZER, MODE BS-200

Chemistry · 193d