FDA 510(k) Application Details - K201299

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K201299
Device Name	Stethoscope, Electronic
Applicant	HD Medical, Inc. 3561 Homestead Road #146 Santa Clara, CA 95051 US Other 510(k) Applications for this Company
Contact	Stephanie Anderson 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	05/15/2020
Decision Date	07/10/2020
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	Y
Expedited Review