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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 the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2022-03-01 under 510(k) 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. The listed applicant is Fresenius Kabi AG. The 510(k) number is K210075.

When did Vigilant Software Suite – Vigilant Master Med receive FDA 510(k) clearance?

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

Who is the listed applicant for Vigilant Software Suite – Vigilant Master Med?

The FDA 510(k) record lists Fresenius Kabi AG as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: PHC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc.K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)Becton DickinsonK242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc.K230665Dose IQ Safety SoftwareBaxter Healthcare CorporationK223606LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc.K211124Dose IQ Safety SoftwareBaxter Healthcare Corporation

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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