FDA 510(k) Application Details - K012264

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K012264
Device Name	Electrocardiograph
Applicant	NATIONAL CUSTOM ENT., INC. 1133 EAST CLIFF RD. BURNSVILLE, MN 55337 US Other 510(k) Applications for this Company
Contact	DON PELLETIER 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	07/18/2001
Decision Date	10/10/2001
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