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NON-CONTACT FOREHEAD INFRARED THERMOMETER - Dt-8806h

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101736

by Shenzhen Everbest Machinery Industry Co., Ltd.

Identifiers

510(k) Number
K101736 FDA 510(k)
FDA Product Code
FLL FDA 510(k)
Models / Variants
Dt-8806h FDA 510(k)
Body Infrared Thermometer FDA 510(k)
Model Dt-8806 FDA 510(k)
Digital Infrared 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 device is a non-contact forehead infrared thermometer and body infrared thermometer designed to measure body temperature by detecting infrared radiation from the forehead. It is intended for use on infants and adults to measure surface and forehead temperature without direct contact with the body. The device operates within a temperature range of 32.0°C to 42.5°C.

The device is supplied as a single-use or reusable item, depending on the model, and is intended for clinical use. It requires no specific storage conditions beyond standard environmental guidelines. The device is regulated under FDA 510(k) clearance, with a decision of substantially equivalent, and is reviewed by the General Hospital advisory committee.

Frequently asked questions

What is the temperature range of this thermometer?

The device measures body temperature within a range of 32.0°C to 42.5°C.

Is this thermometer suitable for infants and adults?

Yes, it is designed for use on both infants and adults to measure surface and forehead temperature.

How is the device supplied?

The device is supplied as a single-use or reusable item, depending on the model.

What is the regulatory status of this device?

The device is regulated under FDA 510(k) clearance with a decision of substantially equivalent.

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: DT8806H | Medical Thermometers | HT Instruments, DT-8806U/DT-8806H/DT-8806R/DT-8816H - cem-instruments.com, PDF Non-Contact Forehead InfraRed Thermometer User Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Everbest Machinery Industry Co., Ltd.

Sources (1)

  • FDA 510(k) K101736 24 fields · synced Oct 6, 2026