FDA 510(k) Application Details - K992197

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K992197
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	ZYMED MEDICAL INSTRUMENTATION 20 NORTH AVIADOR ST. CAMARILLO, CA 93010 US Other 510(k) Applications for this Company
Contact	GRETEL LUMLEY 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	06/30/1999
Decision Date	07/28/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review