DIAGNOSTIC EP CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

ARRHYTHMIA TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Arrhythmia Technologies, Inc. with the FDA for Diagnostic Ep Catheter.

Pre-market Notification Details

Device IDK915563
510k NumberK915563
Device Name:DIAGNOSTIC EP CATHETER
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant ARRHYTHMIA TECHNOLOGIES, INC. 90 WEST PLUMERIA DR. San Jose,  CA  95134
ContactGeorge Savage
CorrespondentGeorge Savage
ARRHYTHMIA TECHNOLOGIES, INC. 90 WEST PLUMERIA DR. San Jose,  CA  95134
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-12
Decision Date1992-03-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994947499 K915563 000

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