FDA 510(k) Application Details - K982193

Device Classification Name	Stethoscope, Esophageal, With Electrical Conductors   More FDA Info for this Device
510(K) Number	K982193
Device Name	Stethoscope, Esophageal, With Electrical Conductors
Applicant	SHORE MEDICAL, INC. 2037 OAK GLEN DR. VISTA, CA 92083 US Other 510(k) Applications for this Company
Contact	MARK RICHARDSON 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	06/22/1998
Decision Date	09/01/1998
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	N
Expedited Review