FDA 510(k) Application Details - K211068

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K211068
Device Name	Stethoscope, Electronic
Applicant	Entac Medical Inc. 680 Oakleaf Office Lane, Suite 201 Memphis, TN 38117 US Other 510(k) Applications for this Company
Contact	Buddy Lyons 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	04/12/2021
Decision Date	08/04/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review