FDA 510(k) Application Details - K243003

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K243003
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	VitalSigns Technology Co., Ltd. 3F., No. 153, Ziqiang S. Rd., Zhubei City Hsinchu County 302042 TW Other 510(k) Applications for this Company
Contact	Jih-liang Juang Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2024
Decision Date	06/17/2025
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