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
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20613994328056 K062198 000
20613994328063 K062198 000
20613994328070 K062198 000
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00613994329561 K062198 000
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00613994604972 K062198 000
20613994801429 K062198 000
20613994801436 K062198 000
20613994802365 K062198 000
20613994802372 K062198 000
20613994327882 K062198 000

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