FDA 510(k) Application Details - K170928

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K170928
Device Name	Stethoscope, Electronic
Applicant	AUM Cardiovascular, Inc. 1405 Heritage Dr, Suite 100 Northfield, MN 55057 US Other 510(k) Applications for this Company
Contact	Marie Johnson Other 510(k) Applications for this Contact
Regulation Number	870.1875   More FDA Info for this Regulation Number
Classification Product Code	DQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2017
Decision Date	08/03/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review