Shenzhen Mindray Bio-Medical Electronics Co., Ltd. - FDA 510(k) Clear...
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
158
Total
158
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Anesthesiology ✕
15 devices
Cleared
Apr 06, 2026
SV70 Ventilator (SV70)
Anesthesiology
269d
Cleared
Aug 28, 2025
SV600, SV800 Ventilator
Anesthesiology
265d
Cleared
Oct 31, 2024
V80 Anesthetic Vaporizer (V80)
Anesthesiology
267d
Cleared
Jun 16, 2023
Mindray SV600 Ventilator, Mindray SV800 Ventilator
Anesthesiology
520d
Cleared
Mar 26, 2021
A8, A9 Anesthesia System
Anesthesiology
255d
Cleared
Oct 24, 2018
Gas Module 3
Anesthesiology
212d
Cleared
Jan 12, 2018
A7 Anesthesia System
Anesthesiology
255d
Cleared
Jan 12, 2018
A5 Anesthesia System
Anesthesiology
255d
Cleared
Oct 27, 2015
A7 Anesthesia System
Anesthesiology
104d
Cleared
Jun 30, 2015
V60 Anesthetic Vaporizer
Anesthesiology
155d
Cleared
Jan 23, 2015
A7 Anesthesia System
Anesthesiology
135d
Cleared
Jan 08, 2008
PM-60 PULSE OXIMETER
Anesthesiology
117d