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FDA 510(k) Application Details - K193027
Device Classification Name
Stethoscope, Esophageal, With Electrical Conductors
More FDA Info for this Device
510(K) Number
K193027
Device Name
Stethoscope, Esophageal, With Electrical Conductors
Applicant
DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849 US
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Contact
Sarah Bennett
Other 510(k) Applications for this Contact
Regulation Number
868.1920
More FDA Info for this Regulation Number
Classification Product Code
BZT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/30/2019
Decision Date
04/02/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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