Nurochek System

Stimulator, Photic, Evoked Response

Cryptych Pty Ltd

The following data is part of a premarket notification filed by Cryptych Pty Ltd with the FDA for Nurochek System.

Pre-market Notification Details

Device IDK200705
510k NumberK200705
Device Name:Nurochek System
ClassificationStimulator, Photic, Evoked Response
Applicant Cryptych Pty Ltd Level 15, Suite 1502, 275 Alfred Street North Sydney,  AU 2060
ContactAngela Roche
CorrespondentRafael Aguila
Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum,  FL  33155 -3708
Product CodeGWE  
CFR Regulation Number882.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-03-18
Decision Date2020-04-23

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