Avita Infrared Therometer With Bluetooth
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110559 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 Avita Infrared Thermometer With Bluetooth is a device intended for the intermittent measurement of human body temperature in people of all ages. It uses infrared sensing technology to measure temperature and features Bluetooth connectivity for data transmission.
The device is operated by patients or clinicians in home or clinical settings to provide temperature readings that assist in monitoring health. It is supplied as a single-use or reusable device, with specific storage requirements, and has received FDA 510K clearance and MDD authorization.
Frequently asked questions
What is the Avita Infrared Thermometer With Bluetooth used for?
The device is intended for the intermittent measurement of human body temperature in people of all ages, using infrared sensing technology to provide readings that assist in health monitoring.
How is the Avita Infrared Thermometer supplied?
The device is supplied as either a single-use or reusable device, depending on the specific model or configuration selected by the user.
What are the storage requirements for this thermometer?
The device has specific storage requirements, though the exact details are not provided in the available information.
Does the Avita Infrared Thermometer have regulatory approvals?
Yes, the device has received FDA 510K clearance and MDD authorization, indicating it meets regulatory requirements for safety and performance.
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 INFRARED THEROMETER WITH BLUETOOTH by AVITA CORPORATION | FDA 510 ..., AVITA INFRARED THEROMETER WITH BLUETOOTH (K110559) — FDA 510 (k ..., PDF K110559 - Avita Infrared Therometer With Bluetooth
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K110559 | Class II | Active |
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Manufacturer
- Manufacturer
- Avita Corporation
Sources (2)
- FDA 510(k) K110559 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026