FDA 510(k) Application Details - K051730

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K051730
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	GLOBAL INSTRUMENTATION, LLC 8104 CAZENOVIA ROAD MANLIUS, NY 13104 US Other 510(k) Applications for this Company
Contact	CRAIG SELLERS Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2005
Decision Date	09/26/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review