FDA 510(k) Application Details - K991007

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K991007
Device Name	Automated External Defibrillators (Non-Wearable)
Applicant	KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 DES MOINES, IA 50321 US Other 510(k) Applications for this Company
Contact	LORNE SCHARNBERG 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	03/26/1999
Decision Date	08/23/1999
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