FDA 510(k)

NewTom 5G XL

K 號：K183448 · 2019-03-08

決定日期2019-03-08

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

NewTom 5G XL is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2019-03-08 under 510(k) number K183448. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NewTom 5G XL?

NewTom 5G XL is a medical device that received FDA 510(k) clearance on 2019-03-08. The listed applicant is Cefla S.C.. The 510(k) number is K183448.

When did NewTom 5G XL receive FDA 510(k) clearance?

NewTom 5G XL received FDA 510(k) clearance on 2019-03-08, under 510(k) number K183448.

Who is the listed applicant for NewTom 5G XL?

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

What is the FDA product code for NewTom 5G XL?

The FDA product code for NewTom 5G XL is JAK.

其他以 Cefla S.C. 為申請人之記錄

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相關器械（代碼：JAK）

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。

K261125BodyTom 64 (NL4100)；OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 觀察階段 6.0Fujifilm Corporation K253836FCT iStream 階段 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770卡迪克套件GE Medical Systems SCS K253560強化版PCCT邊界Ge Medical Systems, LLC

官方來源

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