Medical Device Manufacturer · CN , Shanghai

Guangdong Biolight Meditech Co., Ltd. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2008

Recent clearances: Patient Monitor

21
Total
21
Cleared
0
Denied

Guangdong Biolight Meditech Co., Ltd. has 21 FDA 510(k) cleared medical devices. Based in Shanghai, CN.

Historical record: 21 cleared submissions from 2008 to 2019. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Guangdong Biolight Meditech Co., Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Mid-Link Consulting Co, Ltd. as regulatory consultant.

FDA 510(k) Regulatory Record - Guangdong Biolight Meditech Co., Ltd.

21 devices
1-21 of 21
Cleared Apr 05, 2019
Patient Monitor
K181919 · MWI
Cardiovascular · 261d
Cleared May 24, 2017
Central Monitoring System
K170514 · MHX
Cardiovascular · 92d
Cleared Jan 04, 2017
Truscope Ultra Patient Monitor
K162234 · MWI
Cardiovascular · 148d
Cleared Nov 03, 2016
Electronic Sphygmomanometer
K160349 · DXN
Cardiovascular · 269d
Cleared Sep 07, 2016
Central Monitoring System
K153580 · HGM
Obstetrics & Gynecology · 267d
Cleared Feb 25, 2016
VITAL SIGNS MONITOR
K153135 · MWI
Cardiovascular · 118d
Cleared Feb 09, 2016
Electronic Thermometer
K152739 · FLL
General Hospital · 139d
Cleared Jan 06, 2016
Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
K151287 · DQA
Anesthesiology · 237d
Cleared Jun 11, 2014
DIGITAL ELECTROCARDIOGRAPH
K131858 · DPS
Cardiovascular · 352d
Cleared Jun 06, 2014
HANDHELD MONITOR
K131762 · MWI
Cardiovascular · 354d
Cleared May 15, 2014
FETAL MONITORS
K131941 · HGM
Obstetrics & Gynecology · 322d
Cleared Feb 18, 2014
A SERIES AND Q SERIES PATIENT MONITORS
K131898 · MWI
Cardiovascular · 238d
Cleared Jul 15, 2013
TRUSCOPE SERIES PATIENT MONITOR
K131763 · MHX
Cardiovascular · 28d
Cleared Jun 29, 2012
ANY VIEW PATIENT MONITORS
K120193 · MWI
Cardiovascular · 158d
Cleared May 01, 2012
VITAL SIGNS MONITOR
K113833 · MWI
Cardiovascular · 126d
Cleared Jan 27, 2012
FINGERTIP PULSE OXIMETER
K112804 · DQA
Anesthesiology · 122d
Cleared Oct 24, 2011
PATIENT MONITOR
K112803 · MHX
Cardiovascular · 27d
Cleared Sep 24, 2010
PATIENT MONITOR
K102040 · MHX
Cardiovascular · 67d
Cleared Sep 08, 2010
HANDHELD PULSE OXIMETER MODEL M800
K101694 · DQA
Anesthesiology · 84d
Cleared Apr 08, 2010
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
K100046 · MHX
Cardiovascular · 90d
Cleared Sep 12, 2008
FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700
K081712 · DQA
Anesthesiology · 87d
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