FDA 510(k) Application Details - K242971

Device Classification Name	Stethoscope, Electronic   More FDA Info for this Device
510(K) Number	K242971
Device Name	Stethoscope, Electronic
Applicant	Heroic Faith International Ltd. 18F., No. 460, Sec. 4, Xinyi Rd., Xinyi Dist. Taipei 110 TW Other 510(k) Applications for this Company
Contact	Cheng Yuan-Ren 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	09/26/2024
Decision Date	11/25/2024
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