AVIAFIT— 510(k) K111720

Substantially Equivalent

Flowmedic , Ltd.

FDA 510(k) clearance K111720 for AVIAFIT, Substantially Equivalent on 2011-09-16. Applicant: Flowmedic , Ltd.. Device class: 2.

Clearance details

Applicant: Flowmedic , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2011-06-20
Decision date: 2011-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, 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.