FDA 510(k)

1NEED Pro

K 號：K243472 · 2025-03-19

決定日期2025-03-19

產品代碼QAI

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

1NEED Pro is the device name listed in this FDA 510(k) record. The listed applicant is Campomats S.R.L.. It received FDA 510(k) clearance on 2025-03-19 under 510(k) number K243472. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 1NEED Pro?

1NEED Pro is a medical device that received FDA 510(k) clearance on 2025-03-19. The listed applicant is Campomats S.R.L.. The 510(k) number is K243472.

When did 1NEED Pro receive FDA 510(k) clearance?

1NEED Pro received FDA 510(k) clearance on 2025-03-19, under 510(k) number K243472.

Who is the listed applicant for 1NEED Pro?

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

What is the FDA product code for 1NEED Pro?

The FDA product code for 1NEED Pro is QAI.

相關器械（代碼：QAI）

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官方來源

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