700-F SERIES STIMULATION ELECTRODES

Dc-defibrillator, Low-energy, (including Paddles)

CARDIOTRONICS SYSTEMS, INC.

The following data is part of a premarket notification filed by Cardiotronics Systems, Inc. with the FDA for 700-f Series Stimulation Electrodes.

Pre-market Notification Details

Device IDK964469
510k NumberK964469
Device Name:700-F SERIES STIMULATION ELECTRODES
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant CARDIOTRONICS SYSTEMS, INC. 5966 LA PLACE CT. Carlsbad,  CA  92008
ContactTim J Way
CorrespondentTim J Way
CARDIOTRONICS SYSTEMS, INC. 5966 LA PLACE CT. Carlsbad,  CA  92008
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-07
Decision Date1996-12-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.