FDA 510(k)

HEBE (NP0000763)

K 號：K241733 · 2025-04-16

決定日期2025-04-16

產品代碼PBX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

HEBE (NP0000763) is the device name listed in this FDA 510(k) record. The listed applicant is Novasonix Technology S.L.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K241733. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HEBE (NP0000763)?

HEBE (NP0000763) is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Novasonix Technology S.L.. The 510(k) number is K241733.

When did HEBE (NP0000763) receive FDA 510(k) clearance?

HEBE (NP0000763) received FDA 510(k) clearance on 2025-04-16, under 510(k) number K241733.

Who is the listed applicant for HEBE (NP0000763)?

The FDA 510(k) record lists Novasonix Technology S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEBE (NP0000763)?

The FDA product code for HEBE (NP0000763) is PBX.

相關器械（代碼：PBX）

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官方來源

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