510(k) K905652

MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000 by Daily Medical Products, Inc. — Product Code FLL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 14, 1991
Date Received: December 18, 1990
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 Daily Medical Products, Inc.

K914005 — FIBEROPTIC TYMPANIC THERMOMETER, MODEL 6000 (July 30, 1992)
K905568 — TOPICAL COOLING PAD, MODEL 7000 (January 23, 1991)
K896975 — CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 (February 5, 1990)
K896971 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 (February 5, 1990)
K896974 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 (February 5, 1990)
K896972 — CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 (February 5, 1990)
K896973 — CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 (February 5, 1990)

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K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT (May 22, 2025)
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)