Nurochek System
K-Number: K200705 · 2020-04-23
ApplicantCryptych Pty, Ltd.
Decision Date2020-04-23
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Nurochek System is a medical device manufactured by Cryptych Pty, Ltd.. It received FDA 510(k) clearance on 2020-04-23 under approval 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. It is manufactured by Cryptych Pty, Ltd.. The 510(k) number is K200705.
When was Nurochek System approved by the FDA?
Nurochek System received FDA 510(k) clearance on 2020-04-23, under approval number K200705.
What company makes Nurochek System?
Nurochek System is manufactured by Cryptych Pty, Ltd..
What is the FDA product code for Nurochek System?
The FDA product code for Nurochek System is GWE.
Other Devices by Cryptych Pty, Ltd.
Related Devices (Code: GWE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.