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510(k) K200705

Nurochek System by Cryptych Pty, Ltd. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2020
Date Received
March 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

Other clearances by Cryptych Pty, Ltd.

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