Nurochek System— 510(k) K200705

Substantially Equivalent

Cryptych Pty, Ltd.

FDA 510(k) clearance K200705 for Nurochek System, Substantially Equivalent on 2020-04-23. Applicant: Cryptych Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Cryptych Pty, Ltd.
Product code: Code GWE
Device class: Class 2
Regulation: 21 CFR 882.1890
Advisory panel: Neurology
Date received: 2020-03-18
Decision date: 2020-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Sydney, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.