FDA 510(k) Application Details - K041026

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K041026
Device Name	Electrode, Electrocardiograph
Applicant	AMBU, INC. 611 NORTH HAMMONDS FERRY ROAD LINTHICUM, MD 21090-1356 US Other 510(k) Applications for this Company
Contact	SANJAY PARIKH Other 510(k) Applications for this Contact
Regulation Number	870.2360   More FDA Info for this Regulation Number
Classification Product Code	DRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2004
Decision Date	06/28/2004
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