FDA 510(k) Application Details - K042022

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K042022
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	DATRIX, INC. DBA OF JON BARRON, INC. 340 STATE PLACE ESCONDIDO, CA 92029 US Other 510(k) Applications for this Company
Contact	LAURA M LUHMANN 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	07/28/2004
Decision Date	08/12/2004
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	Y
Expedited Review