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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K203082
Device Name Insight Infrared Video Goggles
Applicant
Vestibular First
9 Mather Ave.
Broomall,  PA  19008
Applicant Contact Helena Esmonde
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number882.1460
Classification Product Code
GWN  
Date Received10/13/2020
Decision Date 11/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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