Falcon/Xpress (Falcon/Xpress)— 510(k) K242662

Substantially Equivalent

Viasonix , Ltd.

FDA 510(k) clearance K242662 for Falcon/Xpress (Falcon/Xpress), Substantially Equivalent on 2024-12-18. Applicant: Viasonix , Ltd.. Device class: 2.

Clearance details

Applicant: Viasonix , Ltd.
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 2024-09-04
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Anana, IL

Download summary PDF View on FDA.gov ↗

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