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FDA 510(k)

Humask Pro Vision, Humask Pro Vision 3000

K-Number: K222551 · 2022-11-10

ApplicantEntreprise Premont, Inc.
Decision Date2022-11-10
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Humask Pro Vision, Humask Pro Vision 3000 is a medical device manufactured by Entreprise Premont, Inc.. It received FDA 510(k) clearance on 2022-11-10 under approval number K222551. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Humask Pro Vision, Humask Pro Vision 3000?

Humask Pro Vision, Humask Pro Vision 3000 is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Entreprise Premont, Inc.. The 510(k) number is K222551.

When was Humask Pro Vision, Humask Pro Vision 3000 approved by the FDA?

Humask Pro Vision, Humask Pro Vision 3000 received FDA 510(k) clearance on 2022-11-10, under approval number K222551.

What company makes Humask Pro Vision, Humask Pro Vision 3000?

Humask Pro Vision, Humask Pro Vision 3000 is manufactured by Entreprise Premont, Inc..

What is the FDA product code for Humask Pro Vision, Humask Pro Vision 3000?

The FDA product code for Humask Pro Vision, Humask Pro Vision 3000 is FXX.

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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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