Avita Piccolo/Exato Infared Ear Thermometer (ts2 & Ts4 Series)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K010462 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 electronic clinical thermometer designed for measuring body temperature via the ear canal. It is classified under product code FLL and has been determined to be substantially equivalent to a legally marketed device.
The device received FDA 510(k) clearance (K010462) on April 11, 2001, following submission on February 16, 2001. It is intended for use in general hospital settings and is manufactured by Avita Corporation.
Frequently asked questions
What is the AVITA PICCOLO/EXATO Infrared Ear Thermometer used for?
It is designed to measure body temperature via the ear canal, intended for use in general hospital settings as an electronic clinical thermometer.
How is the AVITA PICCOLO/EXATO Infrared Ear Thermometer supplied or powered?
The device data does not specify power source, battery type, or supply format; therefore, no details on how it is supplied or powered can be provided from the given information.
Is the AVITA PICCOLO/EXATO Infrared Ear Thermometer sterile or single-use?
The device data does not mention sterility, single-use design, or reusable components; thus, no conclusion can be drawn about its sterility or usage lifecycle from the provided details.
What models or sizes are available for the AVITA PICCOLO/EXATO Infrared Ear Thermometer?
The device is available in the TS2 and TS4 series, as indicated in the product name; no further size variations or additional models are specified in the data.
What regulatory pathway was used for the AVITA PICCOLO/EXATO Infrared Ear Thermometer?
It received FDA 510(k) clearance (K010462) on April 11, 2001, following a traditional submission on February 16, 2001, and was determined to be substantially equivalent to a legally marketed device.
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: Avita Piccolo/Exato Infared Ear Thermometer (Ts2 & Ts4 Series) (K010462 ..., AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 510 (k ..., PDF K010462 - Avita Piccolo/Exato Infared Ear Thermometer (Ts2 & Ts4 Series)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010462 | Class II | Active |
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Manufacturer
- Manufacturer
- Avita Corporation
Sources (1)
- FDA 510(k) K010462 24 fields · synced Oct 1, 2026