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FDA 510(k)

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

K-Number: K251025 · 2025-12-29

ApplicantCovidien, LLC
Decision Date2025-12-29
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2025-12-29 under approval number K251025. The device is classified under product code BZT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) is a medical device that received FDA 510(k) clearance on 2025-12-29. It is manufactured by Covidien, LLC. The 510(k) number is K251025.

When was Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) approved by the FDA?

Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) received FDA 510(k) clearance on 2025-12-29, under approval number K251025.

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

Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) is manufactured by Covidien, LLC.

What is the FDA product code for Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)?

The FDA product code for Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) is BZT.

Related Clinical Trials

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Related Devices (Code: BZT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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