FOCUS EMG DEVICE

Electromyograph, Diagnostic

TELEEMG, LLC USA

The following data is part of a premarket notification filed by Teleemg, Llc Usa with the FDA for Focus Emg Device.

Pre-market Notification Details

Device IDK102610
510k NumberK102610
Device Name:FOCUS EMG DEVICE
ClassificationElectromyograph, Diagnostic
Applicant TELEEMG, LLC USA 65 ARLINGTON ROAD Woburn,  MA  01801
ContactJoe F Jabre, M.d.
CorrespondentJoe F Jabre, M.d.
TELEEMG, LLC USA 65 ARLINGTON ROAD Woburn,  MA  01801
Product CodeIKN  
CFR Regulation Number890.1375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-10
Decision Date2011-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04650075330074 K102610 000

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