DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

Automated External Defibrillators (non-wearable)

DEFIBTECH, LLC

The following data is part of a premarket notification filed by Defibtech, Llc with the FDA for Ddu-2300 Semiautomatic External Defibrillator And Accessories.

Pre-market Notification Details

Device IDK081259
510k NumberK081259
Device Name:DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
ClassificationAutomated External Defibrillators (non-wearable)
Applicant DEFIBTECH, LLC 741 BOSTON POST ROAD Guilford,  CT  06437
ContactEd Horton
CorrespondentEd Horton
DEFIBTECH, LLC 741 BOSTON POST ROAD Guilford,  CT  06437
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-02
Decision Date2009-06-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815098020492 K081259 000
10815098020505 K081259 000
10815098020451 K081259 000
00815098020201 K081259 000
00815098020225 K081259 000
00815098020232 K081259 000
00815098020393 K081259 000
00815098020416 K081259 000
00815098020447 K081259 000
00815098020454 K081259 000
10815098020499 K081259 000

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