FDA 510(k) Application Details - K151319

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K151319
Device Name	Stethoscope, Electronic
Applicant	Eko Devices, Inc. 2600 10th St, Suite 260 Berkeley, CA 94710 US Other 510(k) Applications for this Company
Contact	Connor Landgraf 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	05/18/2015
Decision Date	08/28/2015
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