AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

Electrode, Needle

AXON SYSTEMS, INC.

The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Axon Systems Subdermal Needle Electrodes.

Pre-market Notification Details

Device IDK050194
510k NumberK050194
Device Name:AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
ClassificationElectrode, Needle
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 CodeGXZ  
CFR Regulation Number882.1350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-27
Decision Date2005-04-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994871497 K050194 000
20613994327936 K050194 000
20613994327943 K050194 000
20613994327950 K050194 000
20613994327967 K050194 000
20613994327998 K050194 000
20613994470984 K050194 000
00613994329530 K050194 000
00613994329554 K050194 000
00613994871480 K050194 000
20613994327929 K050194 000

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