ECLIPSE NEUROLOGICAL WORKSTATION

Stimulator, Electrical, Evoked Response

AXON SYSTEMS, INC.

The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Eclipse Neurological Workstation.

Pre-market Notification Details

Device IDK050798
510k NumberK050798
Device Name:ECLIPSE NEUROLOGICAL WORKSTATION
ClassificationStimulator, Electrical, Evoked Response
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 CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-29
Decision Date2005-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169072053 K050798 000
00643169553057 K050798 000
00643169553071 K050798 000
00643169553088 K050798 000
00643169793873 K050798 000
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00643169071704 K050798 000
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00643169071759 K050798 000
00643169071773 K050798 000
00643169071827 K050798 000
00643169071865 K050798 000
00643169071872 K050798 000
00643169071933 K050798 000
00643169071940 K050798 000
00643169523548 K050798 000

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