Data / Medical devices / China / Guangdong Biolight Meditech Co., Ltd
Guangdong Biolight Meditech Co., Ltd: FDA-registered device maker in Zhuhai Guangdong, China, 16 510(k) clearances
Guangdong Biolight Meditech Co., Ltd is registered with the FDA (registration 3007305624) in Zhuhai Guangdong, China. It lists 19 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 5, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007305624
- Address
- No.9 Yonghe Road Hi-tech Zone, Zhuhai Guangdong, China, 519085
- Owner or operator
- Guangdong Biolight Meditech Co., Ltd (10027195)
- Roles
- Manufacturer
- First device listed
- October 11, 2008
- Registered through
- 2026
- Brand names listed
- ARGUS LSM Pro, ARGUS LSM Patient Monitor, AnyView A8, AnyView A6 and M9500 Patient Monitor, AnyView A8, AnyView A6, AnyView A5, AnyView A3 patient monitor, AnyView A8,AnyView A6,AnyView A5, AnyView A3,Q2,Q3,Q4,Q5,Q6,Q7 Patient monitor, E30 Digital Electrocardiograph, E70 Digital Electrocardiograph, E80 Digital Electrocardiograph, Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 5, 2019 | K181919 | Patient Monitor | MWI | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| November 3, 2016 | K160349 | Electronic Sphygmomanometer | DXN | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| February 25, 2016 | K153135 | VITAL SIGNS MONITOR | MWI | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| January 6, 2016 | K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D | DQA | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| June 11, 2014 | K131858 | DIGITAL ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| June 6, 2014 | K131762 | HANDHELD MONITOR | MWI | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| February 27, 2014 | K131876 | M SERIES PATIENT MONITOR | MHX | Substantially Equivalent | Mid-Link Consulting Co, Ltd. | accessdata.fda.gov |
| February 18, 2014 | K131898 | A SERIES AND Q SERIES PATIENT MONITORS | MWI | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| July 15, 2013 | K131763 | TRUSCOPE SERIES PATIENT MONITOR | MHX | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| June 29, 2012 | K120193 | ANY VIEW PATIENT MONITORS | MWI | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| January 27, 2012 | K112804 | FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| October 24, 2011 | K112803 | PATIENT MONITOR | MHX | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| September 24, 2010 | K102040 | PATIENT MONITOR | MHX | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| September 8, 2010 | K101694 | HANDHELD PULSE OXIMETER MODEL M800 | DQA | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| April 8, 2010 | K100046 | M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 | MHX | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| September 12, 2008 | K081712 | FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 | DQA | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
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Updated April 5, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.