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510(k) K932204

E-Z THERM 3 SECOND THERMOMETER by North American Technical Services Corp. — Product Code FLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
May 6, 1993
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 North American Technical Services Corp.

  • K974321 — HYDROTONE (June 22, 1998)
  • K970592 — N/A (June 13, 1997)
  • K970590 — N/A (June 13, 1997)
  • K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (November 8, 1996)
  • K953440 — ELLMAN LAPTRODE (August 29, 1995)
  • K944558 — ELLMAN VAPOR-VAC II (April 28, 1995)
  • K944730 — MASSAGER (February 14, 1995)
  • K914364 — ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. (September 10, 1992)

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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)
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