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FDA 510(k)

健康連接系統(IDA)

K 號:K163664 · 2017-09-18

決定日期2017-09-18
產品代碼NDC
諮詢委員會AN
決定相當於

器材摘要

Health-e-Connect System with IDA is the device name listed in this FDA 510(k) record. The listed applicant is Alr Technologies. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K163664. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Health-e-Connect System with IDA?

Health-e-Connect System with IDA is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Alr Technologies. The 510(k) number is K163664.

When did Health-e-Connect System with IDA receive FDA 510(k) clearance?

Health-e-Connect System with IDA received FDA 510(k) clearance on 2017-09-18, under 510(k) number K163664.

Who is the listed applicant for Health-e-Connect System with IDA?

The FDA 510(k) record lists Alr Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Health-e-Connect System with IDA?

The FDA product code for Health-e-Connect System with IDA is NDC.

相關臨床試驗

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相關器械(代碼:NDC)

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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