FDA 510(k)

NemoFAB

K 號：K192475 · 2020-04-23

決定日期2020-04-23

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

NemoFAB is the device name listed in this FDA 510(k) record. The listed applicant is Software Nemotec S.L.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K192475. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NemoFAB?

NemoFAB is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Software Nemotec S.L.. The 510(k) number is K192475.

When did NemoFAB receive FDA 510(k) clearance?

NemoFAB received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192475.

Who is the listed applicant for NemoFAB?

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

What is the FDA product code for NemoFAB?

The FDA product code for NemoFAB is LLZ.

其他以 Software Nemotec S.L. 為申請人之記錄

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相關器械（代碼：LLZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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