COCET Digital Thermometer - KFT-03
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182652 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 COCET Digital Thermometer is a medical-grade device classified as a Digital Thermometer (Product Code: FLL). It measures oral, rectal, and axillary body temperatures with high precision, providing rapid digital readings for clinical assessment. Designed for general hospital use, it ensures accurate temperature monitoring to support patient care and diagnostic processes.
Supplied as a reusable device, the COCET Digital Thermometer is intended for use in hospital settings and requires proper sterilization between patients. Each model (KFT-01 through KFT-10) may vary in specific features or probe configurations, as detailed in the manufacturer’s specifications. Authorized under FDA 510K and MDR, compliance with regulatory standards ensures reliability and safety in clinical environments.
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 | K182652 | Class II | Active |
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Manufacturer
- Manufacturer
- Kangfu Medical Equipment Factory
Sources (2)
- FDA 510(k) K182652 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026