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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 the device name listed in this FDA 510(k) record. The listed applicant is Poskom Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) 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. The listed applicant is Poskom Co., Ltd.. The 510(k) number is K250976.

When did Airbile-100 receive FDA 510(k) clearance?

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

Who is the listed applicant for Airbile-100?

The FDA 510(k) record lists Poskom Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Airbile-100?

The FDA product code for Airbile-100 is IZL.

Other records listing Poskom Co., Ltd. as applicant

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.

K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)K222896AirRay

Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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