Vyntus BODY— 510(k) K190853

Substantially Equivalent

Vyaire Medical, Inc.

FDA 510(k) clearance K190853 for Vyntus BODY, Substantially Equivalent on 2019-08-16. Applicant: Vyaire Medical, Inc.. Device class: 2.

Clearance details

Applicant: Vyaire Medical, Inc.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 2019-04-02
Decision date: 2019-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mettawa, IL, 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.