Philips Self-Adhesive Electrodes

Electrode, Cutaneous

PHILIPS CONSUMER LIFESTYLE

The following data is part of a premarket notification filed by Philips Consumer Lifestyle with the FDA for Philips Self-adhesive Electrodes.

Pre-market Notification Details

Device IDK151033
510k NumberK151033
Device Name:Philips Self-Adhesive Electrodes
ClassificationElectrode, Cutaneous
Applicant PHILIPS CONSUMER LIFESTYLE 1600 SUMMER STREET Stamford,  CT  06905
ContactMarta Walker
CorrespondentMarta Walker
PHILIPS CONSUMER LIFESTYLE 1600 SUMMER STREET Stamford,  CT  06905
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-17
Decision Date2015-07-28
Summary:summary

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