FDA 510(k) Application Details - K032421

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K032421
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	AMBU, INC. 611 NORTH HAMMONDS FERRY RD. LINTHICUM, MD 21090-1356 US Other 510(k) Applications for this Company
Contact	SANJAY PARIKH Other 510(k) Applications for this Contact
Regulation Number	870.5310   More FDA Info for this Regulation Number
Classification Product Code	MKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2003
Decision Date	02/27/2004
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