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Infrared Forehead Thermometer BSX976

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202296

by Shenzhen BSX Technology Electronics Co., Ltd.

Identifiers

510(k) Number
K202296 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 Forehead Thermometer BSX976 is a non-contact, infrared-based device designed to measure core body temperature via the forehead. It utilises thermal imaging technology to provide rapid, accurate readings without physical contact, making it suitable for clinical and home use in assessing fever or hypothermia.

This single-use thermometer is intended for use in general hospital settings and is supplied sterile. It complies with FDA 510(k) clearance under the General Hospital advisory committee, with a decision classification of Substantially Equivalent. The device is regulated under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), and its model number must be retained for identification.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen BSX Technology Electronics Co., Ltd.

Sources (2)

  • FDA 510(k) K202296 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026