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FDA 510(k)

VISIONAIR

K-Number: K221892 · 2022-10-05

ApplicantPacificmd Biotech, LLC
Decision Date2022-10-05
Product CodeBXQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VISIONAIR is the device name listed in this FDA 510(k) record. The listed applicant is Pacificmd Biotech, LLC. It received FDA 510(k) clearance on 2022-10-05 under 510(k) 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. The listed applicant is Pacificmd Biotech, LLC. The 510(k) number is K221892.

When did VISIONAIR receive FDA 510(k) clearance?

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

Who is the listed applicant for VISIONAIR?

The FDA 510(k) record lists Pacificmd Biotech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISIONAIR?

The FDA product code for VISIONAIR is BXQ.

Related Devices (Code: BXQ)

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.

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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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