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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K230073
Device Name Okti
Applicant
Compumedics Limited
30-40 Flockhart St.
Abbotsford,  AU 3067
Applicant Contact John Joseph
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received01/10/2023
Decision Date 02/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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