Data / Medical devices / Canada / Thermor Ltd.
Thermor Ltd.: FDA-registered device maker in Newmarket Ontario, Canada, 5 510(k) clearances
Thermor Ltd. is registered with the FDA (registration 3006537699) in Newmarket Ontario, Canada. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006537699
- Address
- 16975 Leslie Street, Newmarket Ontario, Canada, L3Y 9A1
- Owner or operator
- Thermor Ltd. (10037045)
- Roles
- Exporter to the US
- First device listed
- September 4, 2019
- Registered through
- 2026
- Brand names listed
- BIOS Diagnostics 5 Second Digital Thermometer 227DI, BIOS Diagnostics Blood Pressure Monitor/Premium, BD412, BIOS Diagnostics Easy Read Blood Pressure Monitor: BD290, BIOS Diagnostics Fingertip Pulse Oximeter 112PO, BIOS Diagnostics Flexible Fast Read Thermometer 238DI, BIOS Diagnostics Instant Response Fever Thermometer 237DI, BIOS Diagnostics Wrist Blood Pressure Monitor, W250
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| August 25, 2023 | K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| July 22, 2019 | K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| September 19, 2017 | K163518 | Digital Thermometer | FLL | Substantially Equivalent | Joytech Healthcare Co. , Ltd. | accessdata.fda.gov |
| April 22, 2016 | K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| February 12, 1999 | K983887 | UP-GRADE AND UP-GRADE PRO | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated August 25, 2023. 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.