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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251025

Identifiers

510(k) Number: K251025 FDA 510(k)
FDA Product Code: BZT FDA 510(k)
Models / Variants: 90041 FDA 510(k)
90042 FDA 510(k)
90043 FDA 510(k)
90049 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 868.1920 FDA 510(k)
Regulation Number: 868.1920 FDA 510(k)
Advisory Committee: Anesthesiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM is an esophageal stethoscope with electrical conductors designed for the continuous monitoring of core body temperature. It functions by providing accurate temperature measurements during clinical procedures.

This device is available in models 90041, 90042, 90043, and 90049. It is an FDA 510(k) cleared device classified under regulation number 868.1920 within the anesthesiology medical specialty.

Frequently asked questions

What is the primary function of the Mon-a-Therm Esophageal Stethoscope 400TM?

This device is designed for the continuous monitoring of a patient's core body temperature. It utilizes integrated electrical conductors to provide accurate temperature measurements during clinical procedures.

Which specific models are included in this product line?

The Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM is available in four distinct model numbers: 90041, 90042, 90043, and 90049.

What is the regulatory status of this device?

The Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM is an FDA 510(k) cleared device. It is classified under regulation number 868.1920 within the anesthesiology medical specialty.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mon-a-therm™ esophageal stethoscope with temperature sensor 400TM, Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041 ..., Mon-a-Therm Esophageal Stethoscope - K251025 | Medical Device Navigator, Mon-a-Therm™ Esophageal Stethoscope with Temperature… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K251025	Class II	Active

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Manufacturer

Manufacturer: Covidien llc
FDA Applicant: Covidien, LLC

Sources (1)

FDA 510(k) K251025 24 fields · synced Sep 21, 2026