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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, photic, evoked response
510(k) Number K200705
Device Name Nurochek System
Cryptych Pty Ltd
Level 15, Suite 1502, 275 Alfred Street
north sydney,  AU 2060
Applicant Contact angela roche
Accelerated Device Approval Services, LLC
6800 S.W. 40th Street, Ste. 403
ludlum,  FL  33155
Correspondent Contact rafael aguila
Regulation Number882.1890
Classification Product Code
Subsequent Product Code
Date Received03/18/2020
Decision Date 04/23/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No