V-ONESTEP
K-Number: K193285 · 2020-11-20
ApplicantVitromed GmbH
Decision Date2020-11-20
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
V-ONESTEP is a medical device manufactured by Vitromed GmbH. It received FDA 510(k) clearance on 2020-11-20 under approval number K193285. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the V-ONESTEP?
V-ONESTEP is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Vitromed GmbH. The 510(k) number is K193285.
When was V-ONESTEP approved by the FDA?
V-ONESTEP received FDA 510(k) clearance on 2020-11-20, under approval number K193285.
What company makes V-ONESTEP?
V-ONESTEP is manufactured by Vitromed GmbH.
What is the FDA product code for V-ONESTEP?
The FDA product code for V-ONESTEP is MQL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.