FDA 510(k)

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

K号: K253244 · 2026-02-23

决定日期2026-02-23

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Poskom Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250976Airbile-100 K222896AirRay

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。