Cleared Traditional

Nurochek System

K200705 · Cryptych Pty, Ltd. · Neurology

Apr 2020

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K200705 is an FDA 510(k) clearance for the Nurochek System, a Stimulator, Photic, Evoked Response (Class II — Special Controls, product code GWE), submitted by Cryptych Pty, Ltd. (North Sydney, AU). The FDA issued a Cleared decision on April 23, 2020, 36 days after receiving the submission on March 18, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number	K200705 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2020
Decision Date	April 23, 2020
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF