MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE

Automated External Defibrillators (non-wearable)

GRAPHIC CONTROLS CORP.

The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace 1610c Combination Defibrillation, Monitoring And Pacing Electrode.

Pre-market Notification Details

Device IDK983287
510k NumberK983287
Device Name:MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
ClassificationAutomated External Defibrillators (non-wearable)
Applicant GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo,  NY  14240
ContactKathleen Selover
CorrespondentKathleen Selover
GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo,  NY  14240
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-18
Decision Date1998-11-05
Summary:summary

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