FDA 510(k)

Nurochek-II System

K-Number: K231914 · 2023-12-27

Decision Date2023-12-27

Product CodePIW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Nurochek-II System is the device name listed in this FDA 510(k) record. The listed applicant is Headsafe Mfg Pty, Ltd.. It received FDA 510(k) clearance on 2023-12-27 under 510(k) 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. The listed applicant is Headsafe Mfg Pty, Ltd.. The 510(k) number is K231914.

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

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

Who is the listed applicant for Nurochek-II System?

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

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

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

Other records listing Headsafe Mfg 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.

K243426Nurochek-Pro System

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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.