Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

Electrode, Needle, Diagnostic Electromyograph

Natus Manufacturing Limited

The following data is part of a premarket notification filed by Natus Manufacturing Limited with the FDA for Dantec Dcn Disposable Concentric Needle Electrodes-25mm, Dantec Dcn Disposable Concentric Needle Electrodes-37mm, Dantec Dcn Disposable Concentric Needle Electrodes-50mm, Dantec Dcn Disposable Concentric Needle Electrodes-75mm.

Pre-market Notification Details

Device IDK143433
510k NumberK143433
Device Name:Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
ClassificationElectrode, Needle, Diagnostic Electromyograph
Applicant Natus Manufacturing Limited IDA Business Park Gort,  IE
ContactMichael Galvin
CorrespondentMichael Galvin
Natus Manufacturing Limited IDA Business Park Gort,  IE
Product CodeIKT  
CFR Regulation Number890.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-01
Decision Date2015-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382830062619 K143433 000
00382830062602 K143433 000
00382830062596 K143433 000
00382830062589 K143433 000
00382830062572 K143433 000
00382830050654 K143433 000

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