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510(k) K062010

RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES by Global Treasure Industries , Ltd. — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2006
Date Received
July 17, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Global Treasure Industries , Ltd.

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  • K030673 — FLEXIBLE TIP THERMOMETER, MODEL 011206 (April 4, 2003)
  • K030658 — STANDARD THERMOMETER (March 25, 2003)
  • K021052 — MODEL GT010706 ELECTRONIC THERMOMETER (April 9, 2002)

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  • 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)