FDA 510(k) Application Details - K131044

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K131044
Device Name	Stethoscope, Electronic
Applicant	DIACOUSTIC MEDICAL DEVICES (PTY) LTD. 1468 Harwell Avenue Crofton, MD 21114 US Other 510(k) Applications for this Company
Contact	YOLANDA SMITH 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	04/15/2013
Decision Date	09/04/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review