Nurochek-II System— 510(k) K231914

Substantially Equivalent

Headsafe Mfg Pty, Ltd.

FDA 510(k) clearance K231914 for Nurochek-II System, Substantially Equivalent on 2023-12-27. Applicant: Headsafe Mfg Pty, Ltd..

Clearance details

Applicant: Headsafe Mfg Pty, Ltd.
Product code: Code PIW
Advisory panel: Neurology
Date received: 2023-06-29
Decision date: 2023-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Surry Hills, AU

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