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FDA 510(k)

Nurochek-Pro System

K-Number: K243426 · 2025-03-27

ApplicantHeadsafe Mfg Pty, Ltd.
Decision Date2025-03-27
Product CodePIW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nurochek-Pro System is a medical device manufactured by Headsafe Mfg Pty, Ltd.. It received FDA 510(k) clearance on 2025-03-27 under approval number K243426. 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-Pro System?

Nurochek-Pro System is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by Headsafe Mfg Pty, Ltd.. The 510(k) number is K243426.

When was Nurochek-Pro System approved by the FDA?

Nurochek-Pro System received FDA 510(k) clearance on 2025-03-27, under approval number K243426.

What company makes Nurochek-Pro System?

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

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

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

Other Devices by Headsafe Mfg Pty, Ltd.

K231914Nurochek-II System

Related Devices (Code: PIW)

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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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