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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K110696
Device Name NEURO CHECK DEVICE WITH IO-FLEX WIRE
Applicant
Baxano, Inc.
655 River Oaks Pkwy.
San Jose,  CA  95134
Applicant Contact EDWARD SINCLAIR
Correspondent
Baxano, Inc.
655 River Oaks Pkwy.
San Jose,  CA  95134
Correspondent Contact EDWARD SINCLAIR
Regulation Number874.1820
Classification Product Code
ETN  
Date Received03/14/2011
Decision Date 07/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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