FDA 510(k) Application Details - K233521

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K233521
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	QT Medical Inc. 1370 Valley Vista Drive, Suite 266 Diamond Bar, CA 91765 US Other 510(k) Applications for this Company
Contact	Jui-Hung Hung 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	11/01/2023
Decision Date	12/06/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review