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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 K874018
Device Name NEUROPROBE
Applicant
Inovx, Inc.
P.O. Box 887
Los Altos,  CA  94023
Applicant Contact P. H CHAN
Correspondent
Inovx, Inc.
P.O. Box 887
Los Altos,  CA  94023
Correspondent Contact P. H CHAN
Regulation Number874.1820
Classification Product Code
ETN  
Date Received10/02/1987
Decision Date 06/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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