FDA 510(k) Application Details - K130785

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K130785
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTRASSE 77 TELTOW 14513 DE Other 510(k) Applications for this Company
Contact	BERT SCHADOW 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	03/21/2013
Decision Date	07/26/2013
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