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FDA 510(k)

VISIONAIR

K-Number: K221892 · 2022-10-05

Decision Date2022-10-05
Product CodeBXQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VISIONAIR is a medical device manufactured by Pacificmd Biotech, LLC. It received FDA 510(k) clearance on 2022-10-05 under approval number K221892. The device is classified under product code BXQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIONAIR?

VISIONAIR is a medical device that received FDA 510(k) clearance on 2022-10-05. It is manufactured by Pacificmd Biotech, LLC. The 510(k) number is K221892.

When was VISIONAIR approved by the FDA?

VISIONAIR received FDA 510(k) clearance on 2022-10-05, under approval number K221892.

What company makes VISIONAIR?

VISIONAIR is manufactured by Pacificmd Biotech, LLC.

What is the FDA product code for VISIONAIR?

The FDA product code for VISIONAIR is BXQ.

Related Devices (Code: BXQ)

Official Source

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