FDA 510(k) Application Details - K981737

Device Classification Name	Automated External Defibrillators (Non-Wearable)   More FDA Info for this Device
510(K) Number	K981737
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 S CHARNBERG 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	05/18/1998
Decision Date	12/09/1998
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