DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES

Electrode, Needle

AXON SYSTEMS, INC.

The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Disposable Monopolar And Bipolar Stimulator Probes.

Pre-market Notification Details

Device IDK062996
510k NumberK062996
Device Name:DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
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 Received2006-10-02
Decision Date2007-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994910851 K062996 000
20613994327820 K062996 000
20613994327837 K062996 000
20613994327844 K062996 000
00613994329523 K062996 000
20613994802501 K062996 000
20613994802518 K062996 000
00613994870865 K062996 000
00613994870872 K062996 000
00613994870889 K062996 000
00613994871046 K062996 000
00613994871084 K062996 000
00613994877376 K062996 000
20613994327813 K062996 000

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