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Non-contact Infrared Body Thermometer (HTD8808C +2 more)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K203332

by Hetaida Technology Co., Ltd.

Identifiers

510(k) Number
K203332 FDA 510(k)
FDA Product Code
FLL FDA 510(k)
Models / Variants
HTD8808C FDA 510(k)EUDAMED
HTD8818A FDA 510(k)EUDAMED
HTD8816C FDA 510(k)EUDAMED

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)

This device is a non-contact infrared body thermometer, designed to measure core body temperature without physical contact. It utilises infrared technology to detect thermal radiation emitted by the forehead, providing rapid and accurate readings for clinical or home use.

The thermometers are supplied as single-use or reusable devices (as specified by the manufacturer) and are intended for use in general hospital settings. They comply with FDA 510(k) clearance under Special Review (K203332) and the Medical Device Directive (MDD). Storage and handling instructions are manufacturer-specified, though no additional regulatory details on sterility or MRI safety are provided in the data.

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

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hetaida Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K203332 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026