CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE

Electrode, Cutaneous

TECHNOMED EUROPE

The following data is part of a premarket notification filed by Technomed Europe with the FDA for Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/silver Chloride Reusable.

Pre-market Notification Details

Device IDK072016
510k NumberK072016
Device Name:CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE
ClassificationElectrode, Cutaneous
Applicant TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
ContactMaurice Roost
CorrespondentMaurice Roost
TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-23
Decision Date2007-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849593025249 K072016 000
00084959302521 K072016 000
00849593015790 K072016 000
00849593025560 K072016 000
00849593025553 K072016 000
00849593025546 K072016 000
00849593025539 K072016 000
00849593025522 K072016 000
00849593025515 K072016 000
00849593025133 K072016 000
00849593025140 K072016 000
00849593025232 K072016 000
00849593025225 K072016 000
00849593025201 K072016 000
00849593025195 K072016 000
00849593025188 K072016 000
00849593025171 K072016 000
00849593025164 K072016 000
00849593025157 K072016 000
00849593025607 K072016 000

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