FDA 510(k) Application Details - K092853

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K092853
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 MIAMI BEACH, FL 33140 US Other 510(k) Applications for this Company
Contact	YOEL PALOMINO 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	09/16/2009
Decision Date	07/09/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review