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510(k) K152680

TD-1035 Thermometer by Taidoc Technology Corporation — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2016
Date Received
September 18, 2015
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.

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  • K190579 — TD-4183 Blood Glucose Monitoring System (June 4, 2019)
  • K182934 — FORA P100 Blood Pressure Monitoring System (February 12, 2019)
  • K180863 — FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator (December 19, 2018)
  • K181675 — FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System (December 10, 2018)
  • K181588 — POPS! one Blood Glucose Monitoring System (November 30, 2018)
  • K172733 — TD-1035 Thermometer (October 22, 2018)
  • K173511 — ActiveCare TD-4121 Blood Glucose Monitoring System (July 12, 2018)

Other clearances for product code FLL

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  • 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)