Cleared Traditional

Vyntus BODY

K190853 · Vyaire Medical, Inc. · Anesthesiology
Aug 2019
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K190853 is an FDA 510(k) clearance for the Vyntus BODY, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Vyaire Medical, Inc. (Mettawa, US). The FDA issued a Cleared decision on August 16, 2019, 136 days after receiving the submission on April 2, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number K190853 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2019
Decision Date August 16, 2019
Days to Decision 136 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

Similar Devices — BZC Calculator, Pulmonary Function Data

All 89
STS
K240293 · Techbopulm, Ltd. · Sep 2024
Vyntus/SentrySuite Product Line
K183567 · Vyaire Medical · Aug 2019
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. · Nov 2018
COSMED K5 Wearable Metabolic Technology
K162515 · Cosmed Srl · Jun 2017
MiniBox +
K161295 · Pulmone Advanced Medical Devices, Ltd. · Oct 2016
Vyntus / SentrySuite Product Line
K150810 · Carefusion Germany 234 GmbH · Aug 2015