SUNSPOTS PRE-GELLED SURFACE ELECTRODES

Electrode, Cutaneous

AXON SYSTEMS, INC.

The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Sunspots Pre-gelled Surface Electrodes.

Pre-market Notification Details

Device IDK062198
510k NumberK062198
Device Name:SUNSPOTS PRE-GELLED SURFACE ELECTRODES
ClassificationElectrode, Cutaneous
Applicant AXON SYSTEMS, INC. 400-2200 OSER AVE. Hauppauge,  NY  11788
ContactHoward Bailin
CorrespondentHoward Bailin
AXON SYSTEMS, INC. 400-2200 OSER AVE. Hauppauge,  NY  11788
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-01
Decision Date2006-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994802389 K062198 000
20613994327899 K062198 000
20613994328056 K062198 000
20613994328063 K062198 000
20613994328070 K062198 000
20613994328087 K062198 000
20613994328094 K062198 000
20613994328100 K062198 000
20613994328117 K062198 000
00613994329561 K062198 000
00613994604965 K062198 000
00613994604972 K062198 000
20613994801429 K062198 000
20613994801436 K062198 000
20613994802365 K062198 000
20613994802372 K062198 000
20613994327882 K062198 000

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