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FDA 510(k)

Alio醫療遠端監測系統

K 號:K211365 · 2022-03-24

決定日期2022-03-24
產品代碼DRG
諮詢委員會履歷
決定相當於

器材摘要

Alio Medical Remote Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Graftworx, Inc. Dba Alio. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K211365. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alio Medical Remote Monitoring System?

Alio Medical Remote Monitoring System is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Graftworx, Inc. Dba Alio. The 510(k) number is K211365.

When did Alio Medical Remote Monitoring System receive FDA 510(k) clearance?

Alio Medical Remote Monitoring System received FDA 510(k) clearance on 2022-03-24, under 510(k) number K211365.

Who is the listed applicant for Alio Medical Remote Monitoring System?

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

What is the FDA product code for Alio Medical Remote Monitoring System?

The FDA product code for Alio Medical Remote Monitoring System is DRG.

相關臨床試驗

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相關器械(代碼:DRG)

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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