PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS

Automated External Defibrillators (non-wearable)

PADPRO LLC.

The following data is part of a premarket notification filed by Padpro Llc. with the FDA for Padpro System Defibrillator Electrode Adapters.

Pre-market Notification Details

Device IDK003548
510k NumberK003548
Device Name:PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
ClassificationAutomated External Defibrillators (non-wearable)
Applicant PADPRO LLC. P.O.BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
PADPRO LLC. P.O.BOX 7007 Deerfield,  IL  60015
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-17
Decision Date2001-09-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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