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FDA 510(k)

Nurochek-II System

K-Number: K231914 · 2023-12-27

ApplicantHeadsafe Mfg Pty, Ltd.
Decision Date2023-12-27
Product CodePIW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nurochek-II System is a medical device manufactured by Headsafe Mfg Pty, Ltd.. It received FDA 510(k) clearance on 2023-12-27 under approval number K231914. The device is classified under product code PIW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nurochek-II System?

Nurochek-II System is a medical device that received FDA 510(k) clearance on 2023-12-27. It is manufactured by Headsafe Mfg Pty, Ltd.. The 510(k) number is K231914.

When was Nurochek-II System approved by the FDA?

Nurochek-II System received FDA 510(k) clearance on 2023-12-27, under approval number K231914.

What company makes Nurochek-II System?

Nurochek-II System is manufactured by Headsafe Mfg Pty, Ltd..

What is the FDA product code for Nurochek-II System?

The FDA product code for Nurochek-II System is PIW.

Other Devices by Headsafe Mfg Pty, Ltd.

K243426Nurochek-Pro System

Related Devices (Code: PIW)

K161068Ahead 300Brainscope Company, Inc. K181785Modified BrainScope OneBrainscope Company, Inc. K181179BrainScope OneBrainscope Company, Inc. K190815BrainScope TBIBrainscope Company, Inc. K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.

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.

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