FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS

Automated External Defibrillators (non-wearable)

HEARTSTREAM, INC.

The following data is part of a premarket notification filed by Heartstream, Inc. with the FDA for Fore Runner External Defibrillator/defibrillator Pads.

Pre-market Notification Details

Device IDK955628
510k NumberK955628
Device Name:FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS
ClassificationAutomated External Defibrillators (non-wearable)
Applicant HEARTSTREAM, INC. 2401 FOURTH AVE., SUITE 300 Seattle,  WA  98121
ContactLori Glastetter
CorrespondentLori Glastetter
HEARTSTREAM, INC. 2401 FOURTH AVE., SUITE 300 Seattle,  WA  98121
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-11
Decision Date1996-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838029569 K955628 000
00884838023710 K955628 000
00884838023727 K955628 000

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