Falcon HST— 510(k) K242447

Substantially Equivalent

Compumedics Limited

FDA 510(k) clearance K242447 for Falcon HST, Substantially Equivalent on 2025-02-20. Applicant: Compumedics Limited. Device class: 2.

Clearance details

Applicant: Compumedics Limited
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2024-08-16
Decision date: 2025-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbotsford, 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.