Guangdong Biolight Meditech Co., Ltd.

FDA Regulatory Profile

Guangdong Biolight Meditech Co., Ltd. appears in FDA public data with 0 recalls, 21 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on Apr 5, 2019.

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K181919Patient MonitorApr 5, 2019
K170514Central Monitoring SystemMay 24, 2017
K162234Truscope Ultra Patient MonitorJan 4, 2017
K160349Electronic SphygmomanometerNov 3, 2016
K153580Central Monitoring SystemSep 7, 2016
K153135VITAL SIGNS MONITORFeb 25, 2016
K152739Electronic ThermometerFeb 9, 2016
K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DJan 6, 2016
K131858DIGITAL ELECTROCARDIOGRAPHJun 11, 2014
K131762HANDHELD MONITORJun 6, 2014
K131941FETAL MONITORSMay 15, 2014
K131898A SERIES AND Q SERIES PATIENT MONITORSFeb 18, 2014
K131763TRUSCOPE SERIES PATIENT MONITORJul 15, 2013
K120193ANY VIEW PATIENT MONITORSJun 29, 2012
K113833VITAL SIGNS MONITORMay 1, 2012
K112804FINGERTIP PULSE OXIMETERJan 27, 2012
K112803PATIENT MONITOROct 24, 2011
K102040PATIENT MONITORSep 24, 2010
K101694HANDHELD PULSE OXIMETER MODEL M800Sep 8, 2010
K100046M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000Apr 8, 2010