Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)— 510(k) K251025

Name: FDA 510(k) clearance K251025
Creator: U.S. Food and Drug Administration
Published: 2025-12-29

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K251025 for Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049), Substantially Equivalent on 2025-12-29. Applicant: Covidien, LLC. Device class: 2.

Clearance details

Applicant: Covidien, LLC
Product code: Code BZT
Device class: Class 2
Regulation: 21 CFR 868.1920
Advisory panel: Anesthesiology
Date received: 2025-04-02
Decision date: 2025-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZT

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K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French2020-04-02
K140134 — ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE2014-06-16
K111050 — ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR2012-04-12
K092716 — ESOPHAGEAL STETHOSCOPE2009-09-17
K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR2007-12-13

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