FDA 510(k)

Anzai 呼吸門控系統

K 號：K170719 · 2017-04-05

決定日期2017-04-05

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

Anzai Respiratory Gating System is the device name listed in this FDA 510(k) record. The listed applicant is Anzai Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K170719. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anzai Respiratory Gating System?

Anzai Respiratory Gating System is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Anzai Medical Co., Ltd.. The 510(k) number is K170719.

When did Anzai Respiratory Gating System receive FDA 510(k) clearance?

Anzai Respiratory Gating System received FDA 510(k) clearance on 2017-04-05, under 510(k) number K170719.

Who is the listed applicant for Anzai Respiratory Gating System?

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

What is the FDA product code for Anzai Respiratory Gating System?

The FDA product code for Anzai Respiratory Gating System is LHN.

其他以 Anzai Medical Co., Ltd. 為申請人之記錄

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K160432Anzai 呼吸門控系統

相關器械（代碼：LHN）

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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