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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K061639
Device Name ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
Applicant
Axon Systems, Inc.
400-2200 Oser Ave.
Hauppauge,  NY  11788
Applicant Contact HOWARD BAILIN
Correspondent
Axon Systems, Inc.
400-2200 Oser Ave.
Hauppauge,  NY  11788
Correspondent Contact HOWARD BAILIN
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   GWQ   ITX   IYN  
Date Received06/12/2006
Decision Date 11/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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