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 Other 510(k) Applications for this Company
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