← Back to catalogue

Infrared Ear Thermometer ET-100 Series

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041692

by Hangzhou Hua'An Medical & Health Instruments Co.,

Identifiers

510(k) Number
K041692 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 Ear Thermometer ET-100 Series is a digital tympanic thermometer classified under the Infrared Ear Thermometer device type. It measures human body temperature non-invasively by detecting infrared radiation emitted from the tympanic membrane via the auditory canal, providing rapid readings of core body temperature.

This device is intended for intermittent temperature monitoring in general hospital settings and is supplied with 20 disposable hygienic probes for single-use. The ET-100 Series has received FDA 510(k) clearance under the Traditional review pathway, with a clearance decision dated September 13, 2004. It operates digitally and provides readings in both Fahrenheit and Celsius, with a response time of one second.

Frequently asked questions

What types of settings is this infrared ear thermometer designed for, and how quickly does it provide temperature readings?

The ET-100 Series is specifically designed for intermittent temperature monitoring in general hospital settings, ensuring reliable core body temperature readings. It delivers results in just one second, making it ideal for fast-paced clinical environments where efficiency matters.

How is the ET-100 Series supplied, and what does this mean for infection control?

The device comes pre-packaged with 20 disposable hygienic probes, ensuring single-use per patient. This design eliminates cross-contamination risks and aligns with strict infection control protocols in healthcare settings.

What temperature units does the ET-100 Series display, and how does this benefit clinical workflows?

The thermometer provides readings in both Fahrenheit and Celsius, accommodating global clinical practices and reducing the need for manual conversions. This dual-unit display streamlines workflows for providers accustomed to either system.

Is this device reusable, or is it intended for single-use applications?

The ET-100 Series itself is a durable, reusable digital device, but it is supplied with disposable probes for each use. This setup balances cost efficiency with hygiene, as the probe—where direct contact occurs—is discarded after one patient.

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: Ear Thermometers, Wholesale Ear Thermometers Manufacturer & Supplier in ..., INFRARED EAR THERMOMETER, ET-100 SERIES (K041692) — FDA 510 (k ..., HUAAN Infra-Red Ear Thermometer,1 Second, 20 Disposable Hygienic Probe ..., HUA'AN MED ET-100A - Precise Infrared Ear Thermometer, Infrared Ear Thermometer, ET-100D - Hangzhou Hua'an Medical & ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hangzhou Hua'An Medical & Health Instruments Co.,

Sources (1)

  • FDA 510(k) K041692 24 fields · synced Oct 6, 2026