E-Care Infrared Ear Thermometer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113095 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 E-Care Infrared Ear Thermometer is an electronic clinical thermometer that uses an infrared sensor to detect body temperature from the auditory area. It is designed to provide a non-invasive and accurate measurement of body temperature. The device is intended for clinical use, specifically for measuring temperature in the ear. The thermometer operates by detecting infrared radiation emitted by the body, allowing for quick and easy temperature readings.
The E-Care Infrared Ear Thermometer is supplied in models LCT-300 and LCT-600, and is authorized with an FDA 510K clearance. The device is used in a general hospital setting and is classified under product code FLL. It is designed for single-use or reusable applications, although specific details on sterility and storage are not provided. The thermometer is available in various sizes, but exact dimensions are not specified. Regulatory authorizations include FDA 510K clearance, with the device being substantially equivalent to a predicate 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: Product - E-Care Technology Co.，Ltd., LCT-600 - E-Care Technology Co.，Ltd., PDF E-Care Technology Co.,Ltd. G areCHUBEI, E-CARE INFRARED EAR THERMOMETER (K113095) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113095 | Class II | Active |
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Manufacturer
- Manufacturer
- E-Care Technology Co., Ltd.
- FDA Applicant
- E-Care Technology Corporation
Sources (1)
- FDA 510(k) K113095 24 fields · synced Sep 26, 2026