FDA 510(k) Application Details - K092716

Device Classification Name	Stethoscope, Esophageal, With Electrical Conductors   More FDA Info for this Device
510(K) Number	K092716
Device Name	Stethoscope, Esophageal, With Electrical Conductors
Applicant	TRUER MEDICAL INC. 1050 N BATAVIA STREET ORANGE, CA 92867 US Other 510(k) Applications for this Company
Contact	TIM TRUITT 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	09/03/2009
Decision Date	09/17/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review