Guangdong Biolight Meditech Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 21
- Inspections
- 2
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K181919 | Patient Monitor | April 5, 2019 |
| K170514 | Central Monitoring System | May 24, 2017 |
| K162234 | Truscope Ultra Patient Monitor | January 4, 2017 |
| K160349 | Electronic Sphygmomanometer | November 3, 2016 |
| K153580 | Central Monitoring System | September 7, 2016 |
| K153135 | VITAL SIGNS MONITOR | February 25, 2016 |
| K152739 | Electronic Thermometer | February 9, 2016 |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D | January 6, 2016 |
| K131858 | DIGITAL ELECTROCARDIOGRAPH | June 11, 2014 |
| K131762 | HANDHELD MONITOR | June 6, 2014 |
| K131941 | FETAL MONITORS | May 15, 2014 |
| K131898 | A SERIES AND Q SERIES PATIENT MONITORS | February 18, 2014 |
| K131763 | TRUSCOPE SERIES PATIENT MONITOR | July 15, 2013 |
| K120193 | ANY VIEW PATIENT MONITORS | June 29, 2012 |
| K113833 | VITAL SIGNS MONITOR | May 1, 2012 |
| K112804 | FINGERTIP PULSE OXIMETER | January 27, 2012 |
| K112803 | PATIENT MONITOR | October 24, 2011 |
| K102040 | PATIENT MONITOR | September 24, 2010 |
| K101694 | HANDHELD PULSE OXIMETER MODEL M800 | September 8, 2010 |
| K100046 | M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 | April 8, 2010 |