Vyntus Walk

FDA 510(k) K142959 · Carefusion Germany 234 GmbH

Substantially Equivalent

510(k) numberK142959

Submission

Device name
Vyntus Walk
Applicant
Carefusion Germany 234 GmbH
Hoechber, DE
Received
October 14, 2014
Decision date
March 20, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQA – Oximeter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2700
Specialty
Cardiovascular

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Questions and answers

When was Vyntus Walk cleared by the FDA?

Vyntus Walk (K142959) received a 510(k) decision of Substantially Equivalent on March 20, 2015, 157 days after the submission was received.

What is the product code of K142959?

The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.