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FDA 510(k)

AirRay

K-Number: K222896 · 2022-12-20

ApplicantPoskom Co., Ltd.
Decision Date2022-12-20
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AirRay is a medical device manufactured by Poskom Co., Ltd.. It received FDA 510(k) clearance on 2022-12-20 under approval number K222896. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirRay?

AirRay is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Poskom Co., Ltd.. The 510(k) number is K222896.

When was AirRay approved by the FDA?

AirRay received FDA 510(k) clearance on 2022-12-20, under approval number K222896.

What company makes AirRay?

AirRay is manufactured by Poskom Co., Ltd..

What is the FDA product code for AirRay?

The FDA product code for AirRay is IZL.

Other Devices by Poskom Co., Ltd.

K250976Airbile-100 K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

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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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