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Infrared Thermometer TET-351

FDA 510(k)

Class II (US FDA 510(k))

510(k) K220276

by Truly Instrument Limited

Identifiers

510(k) Number
K220276 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 TET-351 is a non-contact clinical thermometer classified as an infrared ear and forehead thermometer. It employs an infrared sensor to measure human body temperature rapidly and accurately, suitable for use in neonatal, pediatric, and adult populations. The device adheres to the definition of a thermometer designed for clinical temperature assessment without physical contact, ensuring precision and ease of use in various settings.

This device is intended for single-use or reusable clinical environments, including general hospital settings, as indicated by its FDA 510(k) clearance under product code FLL. It is supplied as a standalone unit with no additional regulatory restrictions such as MRI safety classifications. The thermometer operates in both home and clinical settings, requiring no special storage conditions beyond standard environmental parameters. Its design ensures compliance with FDA standards for non-invasive temperature measurement.

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: PDF TRULY TET-351 Clinical Infrared Thermometers User Manual, Truly Instrument TET351 Infrared Ear & Forehead Thermometer User Manual, TRULY TET-351 Clinical Infrared Thermometers User Manual, Infrared Ear & Forehead Thermometer TET-351 User Manual | Manualzz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Truly Instrument Limited

Sources (1)

  • FDA 510(k) K220276 24 fields · synced Oct 5, 2026