FDA 510(k) Application Details - K233609

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K233609
Device Name	Stethoscope, Electronic
Applicant	Eko Health, Inc. 2100 Powell Street Suite 300 Emeryville, CA 94608 US Other 510(k) Applications for this Company
Contact	Sam Huang 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	11/13/2023
Decision Date	03/28/2024
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