FDA 510(k) Application Details - K033410

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K033410
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	REMOTE DIAGNOSTIC TECHNOLOGIES LTD. THE OLD COACH HOUSE, THE AV. FARLEIGH WALLOP, BASINGSTOKE HAMPSHIRE RG25 2HT GB Other 510(k) Applications for this Company
Contact	CHRIS HANNAN 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	10/27/2003
Decision Date	03/05/2004
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