510(k) K813468

ACC-U-THERM TEMPERATURE MONITOR by Diatek, Inc. — Product Code FLL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 7, 1982
Date Received: December 11, 1981
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 Diatek, Inc.

K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (May 9, 2002)
K010399 — DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, C (August 14, 2001)
K895703 — DIATEK MODEL 700 THERMOMETER (December 7, 1989)
K872178 — MODIFICATION TO ARKIVE(TM) (January 27, 1988)
K862085 — ARKIVE (TM) (January 12, 1987)
K841827 — ENTEROPORT NUTRITION PUMP (July 27, 1984)
K841859 — SECURA SET (July 3, 1984)
K833568 — DIATEK 600 THERMOMETER SYSTEM (January 10, 1984)
K830565 — SECURA SET SECONDARY ADMIN. SET (March 9, 1983)
K830377 — SECURA SET PRIMARY ADMIN. SET (March 1, 1983)

Other clearances for product code FLL

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K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E10 (June 23, 2025)
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)