R-40 EEG Amplifier

Amplifier, Physiological Signal

LIFELINES LTD.

The following data is part of a premarket notification filed by Lifelines Ltd. with the FDA for R-40 Eeg Amplifier.

Pre-market Notification Details

Device IDK151600
510k NumberK151600
Device Name:R-40 EEG Amplifier
ClassificationAmplifier, Physiological Signal
Applicant LIFELINES LTD. 7 CLARENDON COURT Over Wallop,  GB So20 8hu
ContactMichael Hulin
CorrespondentYolanda Smith
Smith Associates 1468 Harwell Ave Crofton,  MD  21114
Product CodeGWL  
CFR Regulation Number882.1835 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-12
Decision Date2015-10-23
Summary:summary

NIH GUDID Devices

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