510(k) K830819

MODIFICATION ELECTRONIC CLINICAL THERMO- by Mon-A-Therm, Inc. — Product Code FLL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 6, 1983
Date Received: March 15, 1983
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 Mon-A-Therm, Inc.

K885187 — MODEL 1000 ELECTRONIC CLINICAL THERMOMETER (March 8, 1989)
K874519 — MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR (January 29, 1988)
K874522 — MODIFIED MYOCARDIAL TEMPERATURE SENSOR (January 29, 1988)
K875234 — MON-A-THERM'S SKIN TEMPERATURE SENSOR (January 19, 1988)
K874520 — MODIFIED AIRWAY TEMPERATURE SENSOR (January 6, 1988)
K874521 — MODIFIED THERMAL WELL TEMPERATURE SENSOR (January 6, 1988)
K874525 — MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR (January 6, 1988)
K874524 — MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR (January 6, 1988)
K874523 — MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR (January 6, 1988)
K853392 — MON-A-THERM SUBCUTANEOUS TEMP. SENSOR (November 22, 1985)

Other clearances for product code FLL

K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099L (January 8, 2026)
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)