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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 K193027
Device Name Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
Applicant
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell,  TN  37849
Applicant Contact Sarah Bennett
Correspondent
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell,  TN  37849
Correspondent Contact Sarah Bennett
Regulation Number868.1920
Classification Product Code
BZT  
Date Received10/30/2019
Decision Date 04/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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