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FDA 510(k)

Vigilant Software Suite – Vigilant Master Med

K-Number: K210075 · 2022-03-01

ApplicantFresenius Kabi AG
Decision Date2022-03-01
Product CodePHC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vigilant Software Suite – Vigilant Master Med is a medical device manufactured by Fresenius Kabi AG. It received FDA 510(k) clearance on 2022-03-01 under approval number K210075. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vigilant Software Suite – Vigilant Master Med?

Vigilant Software Suite – Vigilant Master Med is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Fresenius Kabi AG. The 510(k) number is K210075.

When was Vigilant Software Suite – Vigilant Master Med approved by the FDA?

Vigilant Software Suite – Vigilant Master Med received FDA 510(k) clearance on 2022-03-01, under approval number K210075.

What company makes Vigilant Software Suite – Vigilant Master Med?

Vigilant Software Suite – Vigilant Master Med is manufactured by Fresenius Kabi AG.

What is the FDA product code for Vigilant Software Suite – Vigilant Master Med?

The FDA product code for Vigilant Software Suite – Vigilant Master Med is PHC.

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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.

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