FALCON— 510(k) K111416

Substantially Equivalent

Viasonix , Ltd.

FDA 510(k) clearance K111416 for FALCON, Substantially Equivalent on 2011-07-15. 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: 2011-05-20
Decision date: 2011-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yonkers, NY, US

Download summary PDF View on FDA.gov ↗

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