FDA 510(k) Application Details - K220099

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K220099
Device Name	Stethoscope, Electronic
Applicant	HomeDiagnostic LLC 3160 De La Cruz Blvd Suite 100 Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Jian Gong 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	01/12/2022
Decision Date	10/20/2022
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