FDA 510(k)

視覺-ICE MRI 冷凍消融控制台，視覺-ICE MRI 接線盒組裝，視覺-ICE MRI 移動連接面板

K 號：K173037 · 2017-11-21

決定日期2017-11-21

產品代碼GEH

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

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel is the device name listed in this FDA 510(k) record. The listed applicant is Galil Medical, Inc.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K173037. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel?

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Galil Medical, Inc.. The 510(k) number is K173037.

When did Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel receive FDA 510(k) clearance?

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel received FDA 510(k) clearance on 2017-11-21, under 510(k) number K173037.

Who is the listed applicant for Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel?

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

What is the FDA product code for Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel?

The FDA product code for Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel is GEH.

其他以 Galil Medical, Inc. 為申請人之記錄

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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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