Nurochek-Pro System— 510(k) K243426

Substantially Equivalent

Headsafe Mfg Pty, Ltd.

FDA 510(k) clearance K243426 for Nurochek-Pro System, Substantially Equivalent on 2025-03-27. Applicant: Headsafe Mfg Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Headsafe Mfg Pty, Ltd.
Product code: Code PIW
Device class: Class 2
Regulation: 21 CFR 882.1450
Advisory panel: Neurology
Date received: 2024-11-04
Decision date: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Surry Hills, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.