FDA 510(k) Application Details - K033642

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K033642
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	MRL, A WELCH ALLYN COMPANY 4341 STATE STREET ROAD SKANEATELES FALLS, NY 13153 US Other 510(k) Applications for this Company
Contact	DAVID KLEMENTOWSKI 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	11/20/2003
Decision Date	05/25/2004
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