FDA 510(k)

MR無線閉鎖系統，型號WGS-100

K 號：K171778 · 2018-03-14

決定日期2018-03-14

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

MR Wireless Gating System, Model WGS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2018-03-14 under 510(k) number K171778. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MR Wireless Gating System, Model WGS-100?

MR Wireless Gating System, Model WGS-100 is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K171778.

When did MR Wireless Gating System, Model WGS-100 receive FDA 510(k) clearance?

MR Wireless Gating System, Model WGS-100 received FDA 510(k) clearance on 2018-03-14, under 510(k) number K171778.

Who is the listed applicant for MR Wireless Gating System, Model WGS-100?

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

What is the FDA product code for MR Wireless Gating System, Model WGS-100?

The FDA product code for MR Wireless Gating System, Model WGS-100 is LNH.

其他以 Ivy Biomedical Systems, Inc. 為申請人之記錄

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相關器械（代碼：LNH）

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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