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FDA 510(k)

Airbile-100

K-Number: K250976 · 2025-12-19

ApplicantPoskom Co., Ltd.
Decision Date2025-12-19
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Airbile-100 is a medical device manufactured by Poskom Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval number K250976. 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 Airbile-100?

Airbile-100 is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Poskom Co., Ltd.. The 510(k) number is K250976.

When was Airbile-100 approved by the FDA?

Airbile-100 received FDA 510(k) clearance on 2025-12-19, under approval number K250976.

What company makes Airbile-100?

Airbile-100 is manufactured by Poskom Co., Ltd..

What is the FDA product code for Airbile-100?

The FDA product code for Airbile-100 is IZL.

Other Devices by Poskom Co., Ltd.

K222896AirRay 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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