Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART— 510(k) K181524

Name: FDA 510(k) clearance K181524
Creator: U.S. Food and Drug Administration
Published: 2018-11-30

Substantially Equivalent

Vyaire Medical, Inc.

FDA 510(k) clearance K181524 for Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART, Substantially Equivalent on 2018-11-30. 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: 2018-06-11
Decision date: 2018-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechber, DE

Download summary PDF View on FDA.gov ↗

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