FDA 510(k)

Nurochek System

K-Number: K200705 · 2020-04-23

Decision Date2020-04-23

Product CodeGWE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Nurochek System is the device name listed in this FDA 510(k) record. The listed applicant is Cryptych Pty, Ltd.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K200705. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nurochek System?

Nurochek System is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Cryptych Pty, Ltd.. The 510(k) number is K200705.

When did Nurochek System receive FDA 510(k) clearance?

Nurochek System received FDA 510(k) clearance on 2020-04-23, under 510(k) number K200705.

Who is the listed applicant for Nurochek System?

The FDA 510(k) record lists Cryptych Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nurochek System?

The FDA product code for Nurochek System is GWE.

Other records listing Cryptych Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.