FDA 510(k) Application Details - K993205

Device Classification Name	Dc-Defibrillator, Low-Energy, (Including Paddles)   More FDA Info for this Device
510(K) Number	K993205
Device Name	Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant	TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	BYRON KAHLER 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	09/24/1999
Decision Date	07/20/2000
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