FDA 510(k)

IVDカプセルPSP；abioSCOPE

K番号: K240041 · 2024-09-25

決定日2024-09-25

製品コードSCX

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

IVD CAPSULE PSP; abioSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Abionic SA. It received FDA 510(k) clearance on 2024-09-25 under 510(k) number K240041. The device is classified under product code SCX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the IVD CAPSULE PSP; abioSCOPE?

IVD CAPSULE PSP; abioSCOPE is a medical device that received FDA 510(k) clearance on 2024-09-25. The listed applicant is Abionic SA. The 510(k) number is K240041.

When did IVD CAPSULE PSP; abioSCOPE receive FDA 510(k) clearance?

IVD CAPSULE PSP; abioSCOPE received FDA 510(k) clearance on 2024-09-25, under 510(k) number K240041.

Who is the listed applicant for IVD CAPSULE PSP; abioSCOPE?

The FDA 510(k) record lists Abionic SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVD CAPSULE PSP; abioSCOPE?

The FDA product code for IVD CAPSULE PSP; abioSCOPE is SCX.

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医療機器の概要

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