Infrared Forehead Thermometer, Model BSX976
FDA 510(k) K202296 · Shenzhen Bsx Technology Electronics Co., Ltd.
510(k) numberK202296
Submission
- Device name
- Infrared Forehead Thermometer, Model BSX976
- Applicant
- Shenzhen Bsx Technology Electronics Co., Ltd.
Shenzhen, CN - Received
- August 13, 2020
- Decision date
- July 23, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLL – Continuous Measurement Thermometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2910
- Specialty
- General Hospital
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
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| K240333 | Wearable Digital Thermometer (T31)FLL · Traditional | Guangdong Genial Technology Co., Ltd. | 10/30/2024SE |
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Questions and answers
When was Infrared Forehead Thermometer, Model BSX976 cleared by the FDA?
Infrared Forehead Thermometer, Model BSX976 (K202296) received a 510(k) decision of Substantially Equivalent on July 23, 2021, 344 days after the submission was received.
What is the product code of K202296?
The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.