FDA 510(k)

日本光電 Afib偵測程序 QP-039P

K 號：K152305 · 2016-04-08

決定日期2016-04-08

產品代碼DSI

諮詢委員會履歷

決定相當於

器材摘要

Nihon Kohden Afib Detection Program QP-039P is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K152305. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nihon Kohden Afib Detection Program QP-039P?

Nihon Kohden Afib Detection Program QP-039P is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K152305.

When did Nihon Kohden Afib Detection Program QP-039P receive FDA 510(k) clearance?

Nihon Kohden Afib Detection Program QP-039P received FDA 510(k) clearance on 2016-04-08, under 510(k) number K152305.

Who is the listed applicant for Nihon Kohden Afib Detection Program QP-039P?

FDA 510(k) 記錄中將 Nihon Kohden Corporation 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Nihon Kohden Afib Detection Program QP-039P?

The FDA product code for Nihon Kohden Afib Detection Program QP-039P is DSI.

其他以 Nihon Kohden Corporation 為申請人之記錄

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相關器械（代碼：DSI）

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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