HTD8823US Non-Contact Infrared Body Thermometer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200159 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 HTD8823US is a non-contact infrared body thermometer designed to measure human body temperature without physical contact. It employs an infrared sensor to detect forehead temperature, enabling rapid and hygienic readings for individuals of all ages. This device falls under the category of electronic clinical thermometers, providing a non-invasive method for temperature assessment.
This thermometer is intended for use in both home and general hospital settings, offering a convenient means of monitoring body temperature. Supplied as a single-use or reusable device (as per user instructions), it adheres to FDA 510(k) clearance and MDD compliance standards. The device is non-magnetic and safe for use in non-MRI environments. Storage and handling follow standard clinical hygiene protocols to ensure accuracy and reliability.
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: HETAIDA HTD8823US USER MANUAL Pdf Download | ManualsLib, HTD8823US Infrared Thermometer Manual, Non-contact Infrared Body Thermometer, model:HTD8823US, Non-contact Infrared Body Thermometer, model:HTD8823US
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 | K200159 | Class II | Active |
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Manufacturer
- Manufacturer
- Hetaida Technology Co., Ltd.
Sources (2)
- FDA 510(k) K200159 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026