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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 K094054
Device Name MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
Applicant
Nuvasive, Inc.
4545 Towne Centre Ct.
San Diego,  CA  92121
Applicant Contact Sheila Bruschi
Correspondent
Nuvasive, Inc.
4545 Towne Centre Ct.
San Diego,  CA  92121
Correspondent Contact Sheila Bruschi
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Code
ETN  
Date Received12/31/2009
Decision Date 05/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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