ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON

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 Tcd Neurovascular Workstation; Elclipse Neurological Workstation With Tcd And Vascular Doppler; Cardiomon.

Pre-market Notification Details

Device IDK061639
510k NumberK061639
Device Name:ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
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  
Subsequent Product CodeGWE
Subsequent Product CodeGWJ
Subsequent Product CodeGWQ
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-12
Decision Date2006-11-01
Summary:summary

NIH GUDID Devices

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