FDA 510(k) Application Details - K221805

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K221805
Device Name	Stethoscope, Electronic
Applicant	Heroic Faith International Ltd. 18F., No. 460, Section 4, Xinyi Road, Xinyi District Taipei City 110 TW Other 510(k) Applications for this Company
Contact	Yuan-Ren Cheng 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	06/22/2022
Decision Date	03/23/2023
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