Infrared Thermometer - FT-F41-BT
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152640 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)
An infrared thermometer is an electronic clinical thermometer that uses an infrared sensor to detect body temperature from the auditory canal. It is designed for use in neonatal, pediatric, and adult populations.
The device is supplied as a reusable clinical thermometer and has received FDA 510(k) clearance under K152640. It is intended for general hospital use and is not sterile or single-use.
Frequently asked questions
What is the Infrared Thermometer FT-F11-BT series used for?
It is designed to detect body temperature from the auditory canal using an infrared sensor and is intended for use in neonatal, pediatric, and adult populations in general hospital settings.
Is the Infrared Thermometer FT-F11-BT series sterile or single-use?
The device is supplied as a reusable clinical thermometer and is not sterile or designated for single-use, meaning it can be cleaned and reused according to manufacturer guidelines.
What regulatory clearance does the Infrared Thermometer FT-F11-BT series have?
It has received FDA 510(k) clearance under submission number K152640, indicating it was found substantially equivalent to a legally marketed predicate device.
Who manufactures the Infrared Thermometer FT-F11-BT series and where are they located?
The device is manufactured by Fudakang Industries Co., Ltd., located at #8 Yinghe Rd., Yuanjiangyuan Management Zone, Changping Town, Dongguan, China, with postal code 523560.
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. Sources consulted: Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT ..., PDF FORM FDA 3881 - Food and Drug Administration, 510 (k) K152640 — Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT ..., PDF FORM FDA 3881 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152640 | Class II | Active |
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Manufacturer
- Manufacturer
- Fudakang Industries Co., Ltd.
Sources (1)
- FDA 510(k) K152640 24 fields · synced Oct 6, 2026