FDA 510(k)

Advantis 平臺

K 號：K222975 · 2023-03-01

申請人Advantis Medical Imaging Single Member P.C.

決定日期2023-03-01

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Advantis Platform is the device name listed in this FDA 510(k) record. The listed applicant is Advantis Medical Imaging Single Member P.C.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K222975. 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 Advantis Platform?

Advantis Platform is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Advantis Medical Imaging Single Member P.C.. The 510(k) number is K222975.

When did Advantis Platform receive FDA 510(k) clearance?

Advantis Platform received FDA 510(k) clearance on 2023-03-01, under 510(k) number K222975.

Who is the listed applicant for Advantis Platform?

The FDA 510(k) record lists Advantis Medical Imaging Single Member P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advantis Platform?

The FDA product code for Advantis Platform is LLZ.

其他以 Advantis Medical Imaging Single Member P.C. 為申請人之記錄

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K202808腦光醫療設備

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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