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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Esophageal, With Electrical Conductors
510(k) Number K251025
Device Name Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
Applicant
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Angelica Medina
Correspondent
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Angelica Medina
Regulation Number868.1920
Classification Product Code
BZT  
Date Received04/02/2025
Decision Date 12/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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