FDA 510(k) Application Details - K014262

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K014262
Device Name	Electrocardiograph
Applicant	COSMED S.R.L. 1129 BLOOMFIELD AVE. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ROBERT SCHIFF Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2001
Decision Date	03/26/2002
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