FDA 510(k)

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

K-번호: K253244 · 2026-02-23

결정일2026-02-23

제품 코드IZL

자문 위원회RA

결정Substantially Equivalent

기기 요약

AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) 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 2026-02-23 under 510(k) number K253244. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)?

AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Poskom Co., Ltd.. The 510(k) number is K253244.

When did AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) receive FDA 510(k) clearance?

AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253244.

Who is the listed applicant for AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)?

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 AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)?

The FDA product code for AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) is IZL.

Poskom Co., Ltd.를 신청인으로 등재한 기타 기록

K250976Airbile-100 K222896AirRay

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