Identifiers
- 510(k) Number
- K201980 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Infrared Thermometer is a non-contact temperature measurement device classified under the nomenclature for diagnostic thermometers. It measures body temperature by detecting infrared radiation emitted from the skin, providing rapid and contactless readings without physical contact.
This device is intended for single-use or reusable applications in general hospital settings, depending on the model. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance under the Traditional pathway and EU MDR compliance. The device is available in standard configurations, with no MRI safety restrictions, and requires proper storage per manufacturer guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201980 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- FDA Applicant
- Contec Medical Systems Co.,Ltd
Sources (2)
- FDA 510(k) K201980 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026