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510(k) K103839

BEHIND EAR GENTLE TOUCH THERMOMETER by Kaz, Inc. — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2011
Date Received
December 30, 2010
Clearance Type
Abbreviated
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 Kaz, Inc.

  • K950116 — THERASTEAM PERSONAL STEAM INHALER (February 10, 1995)

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  • K243082 — Infrared Thermometer (April 25, 2025)
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  • 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)