FDA 510(k) Application Details - K193631

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K193631
Device Name	Stethoscope, Electronic
Applicant	M3DICINE Pty Ltd. Level 1, 88 Brandl Street Eight Mile Plains 4113 AU Other 510(k) Applications for this Company
Contact	Nayyar Hussain 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	12/27/2019
Decision Date	10/09/2020
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