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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tympanostomy
510(k) Number K973740
Device Name ROUND WINDOW E-CATH
Applicant
Neuro-Biometrix, Inc.
7995 E. Prentice Ave.
Englewood,  CO  80111
Applicant Contact MICHAEL H ARENBERG
Correspondent
Neuro-Biometrix, Inc.
7995 E. Prentice Ave.
Englewood,  CO  80111
Correspondent Contact MICHAEL H ARENBERG
Regulation Number874.3880
Classification Product Code
ETD  
Subsequent Product Code
GXY  
Date Received10/01/1997
Decision Date 03/23/1998
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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