FDA 510(k) Application Details - K993788

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K993788
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	NOVACOR DIV. 203 MAIN ST. PMB 166 FLEMINGTON, NJ 08822 US Other 510(k) Applications for this Company
Contact	LYNETTE L HOWARD 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	11/09/1999
Decision Date	08/04/2000
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