FDA 510(k) Application Details - K010794

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K010794
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	MERIDIAN MEDICAL TECHNOLOGIES LTD. 207 AIRPORT RD., WEST BELFAST BT3 9ED IE Other 510(k) Applications for this Company
Contact	RHONA LOVE 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	03/16/2001
Decision Date	05/10/2001
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