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FDA 510(k)

索引 BPM

K 號:K221486 · 2022-08-30

決定日期2022-08-30
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

INDEX BPM is the device name listed in this FDA 510(k) record. The listed applicant is Ya Horng Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K221486. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the INDEX BPM?

INDEX BPM is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Ya Horng Electronic Co., Ltd.. The 510(k) number is K221486.

When did INDEX BPM receive FDA 510(k) clearance?

INDEX BPM received FDA 510(k) clearance on 2022-08-30, under 510(k) number K221486.

Who is the listed applicant for INDEX BPM?

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

What is the FDA product code for INDEX BPM?

The FDA product code for INDEX BPM is DXN.

相關臨床試驗

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相關器械(代碼:DXN)

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。

官方來源

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