FDA 510(k) Application Details - K160016

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K160016
Device Name	Stethoscope, Electronic
Applicant	STRATOSCIENTIFIC, INC. 1574 NORTHWEST 190TH STREET SHORELINE, WA 98177 US Other 510(k) Applications for this Company
Contact	SUMAN MULUMUDI 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	01/05/2016
Decision Date	07/15/2016
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