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510(k) K200159

Non-contact Infrared Body Thermometer, model:HTD8823US by Hetaida Technology Co., Ltd. — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2021
Date Received
January 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Continuous Measurement Thermometer
Device Class
Class II
Regulation Number
880.2910
Review Panel
HO
Submission Type

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.

Other clearances by Hetaida Technology Co., Ltd.

  • K243661 — Electronic Blood Pressure Monitor (February 7, 2025)
  • K241202 — Electric nasal aspirator (HTD2601US) (July 1, 2024)
  • K223170 — Electronic Blood Pressure Monitor, model: HTD6602US (December 5, 2023)
  • K203332 — Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C (February 25, 2021)
  • K180387 — Infrared Ear Thermometer (January 10, 2019)
  • K171888 — Non-contact infrared body thermometer (July 23, 2018)
  • K180385 — Infrared Body Thermometer (May 11, 2018)

Other clearances for product code FLL

  • K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099L (January 8, 2026)
  • K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E10 (June 23, 2025)
  • K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature (June 20, 2025)
  • K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT (May 22, 2025)
  • K243082 — Infrared Thermometer (April 25, 2025)
  • K250401 — AION TempShield™ (March 14, 2025)
  • K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR2 (February 14, 2025)
  • K240333 — Wearable Digital Thermometer (T31) (October 30, 2024)
  • K240223 — FMT Disposable and Autoclavable Temperature Probes (October 25, 2024)
  • K240220 — Aulisa Temperature Module (TM0002) (September 27, 2024)