Cleared Traditional

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

K181524 · Vyaire Medical, Inc. · Anesthesiology
Nov 2018
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K181524 is an FDA 510(k) clearance for the Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Vyaire Medical, Inc. (Hoechber, DE). The FDA issued a Cleared decision on November 30, 2018, 172 days after receiving the submission on June 11, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number K181524 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2018
Decision Date November 30, 2018
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZC — Calculator, Pulmonary Function Data
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1880