FDA 510(k)

CURA 778

K 號：K192590 · 2020-03-05

決定日期2020-03-05

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

CURA 778 is the device name listed in this FDA 510(k) record. The listed applicant is Fmi Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K192590. 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 CURA 778?

CURA 778 is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Fmi Medical Systems, Inc.. The 510(k) number is K192590.

When did CURA 778 receive FDA 510(k) clearance?

CURA 778 received FDA 510(k) clearance on 2020-03-05, under 510(k) number K192590.

Who is the listed applicant for CURA 778?

The FDA 510(k) record lists Fmi Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CURA 778?

The FDA product code for CURA 778 is JAK.

其他以 Fmi Medical Systems, Inc. 為申請人之記錄

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。

K173076CURA 16; ScintCare CT16

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。