K-DEFIB/PACE PEDIATRIC ELECTRODE

Automated External Defibrillators (non-wearable)

KATECHO, INC.

The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-defib/pace Pediatric Electrode.

Pre-market Notification Details

Device IDK954504
510k NumberK954504
Device Name:K-DEFIB/PACE PEDIATRIC ELECTRODE
ClassificationAutomated External Defibrillators (non-wearable)
Applicant KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines,  IA  50321
ContactLorne Scharnberg
CorrespondentLorne Scharnberg
KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines,  IA  50321
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-28
Decision Date1995-11-17

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