FDA 510(k) Application Details - K083382

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K083382
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	SCOTTCARE CORPORATION 4791 WEST 150TH ST. CLEVELAND, OH 44135 US Other 510(k) Applications for this Company
Contact	TIMOTHY J LEYVA Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2008
Decision Date	08/13/2009
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