DEFIB K-PADS

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

KATECHO, INC.

The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for Defib K-pads.

Pre-market Notification Details

Device IDK895662
510k NumberK895662
Device Name:DEFIB K-PADS
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines,  IA  50315
ContactLorne Scharnberg
CorrespondentLorne Scharnberg
KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines,  IA  50315
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-20
Decision Date1990-01-18

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