FDA 510(k) Application Details - K162589

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K162589
Device Name	Stethoscope, Electronic
Applicant	AMERICAN DIAGNOSTIC CORP. 55 COMMERCE DR. HAUPPAUGE, NY 11788 US Other 510(k) Applications for this Company
Contact	Michael Falco 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	09/16/2016
Decision Date	03/10/2017
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