Cleared Traditional

Vyntus Walk

K142959 · Carefusion Germany 234 GmbH · Anesthesiology
Mar 2015
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K142959 is an FDA 510(k) clearance for the Vyntus Walk, a Oximeter (Class II — Special Controls, product code DQA), submitted by Carefusion Germany 234 GmbH (Hoechber, DE). The FDA issued a Cleared decision on March 20, 2015, 157 days after receiving the submission on October 14, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K142959 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2014
Decision Date March 20, 2015
Days to Decision 157 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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