FDA 510(k) Application Details - K161062

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K161062
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	Norav Medical GmbH Otto von Guericke Ring 10 Wiesbaden 65205 DE Other 510(k) Applications for this Company
Contact	David Seal 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	04/15/2016
Decision Date	06/13/2016
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