Data / Medical devices / China / Shenzhen Calibeur Industries Co., Ltd.
Shenzhen Calibeur Industries Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Calibeur Industries Co., Ltd. is registered with the FDA (registration 3012295567) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 15, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012295567
- Address
- No. 11 Bldg., Shiguan Industrial Park, Gongming, Guangming New District, Shenzhen Guangdong, China, 518106
- Owner or operator
- Shenzhen Calibeur Industries Co., Ltd. (10061521)
- Roles
- Manufacturer
- First device listed
- October 24, 2019
- Registered through
- 2026
- Brand names listed
- Infrared Thermometer: DT-8836D, DT-8836W, DT-8836K, DT-8836C, DT-8836B, DT-8836J, DT-8836M, DT-8836Y, DT-8836S, DT-8836L, Infrared Thermometer: DT-8836T, DT-8836P
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 15, 2019 | K191251 | Infared Thermometer | FLL | Substantially Equivalent | Shenzhen Calibeur Industries Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 15, 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.