FDA 510(k) Application Details - K971355

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K971355
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. IRVINE, CA 92612-1601 US Other 510(k) Applications for this Company
Contact	GARY REASONER Other 510(k) Applications for this Contact
Regulation Number	870.5300   More FDA Info for this Regulation Number
Classification Product Code	LDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/1997
Decision Date	07/15/1997
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review