RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

Electrode, Needle

RHYTHMLINK INTERNATIONAL, LLC

The following data is part of a premarket notification filed by Rhythmlink International, Llc with the FDA for Rhythmlink International Subdermal Needle Electrodes.

Pre-market Notification Details

Device IDK022914
510k NumberK022914
Device Name:RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
ClassificationElectrode, Needle
Applicant RHYTHMLINK INTERNATIONAL, LLC 2013 WINDSOR DR. Cayce,  SC  29033
ContactBrett L Netherton
CorrespondentBrett L Netherton
RHYTHMLINK INTERNATIONAL, LLC 2013 WINDSOR DR. Cayce,  SC  29033
Product CodeGXZ  
CFR Regulation Number882.1350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-03
Decision Date2002-12-20
Summary:summary

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