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FDA 510(k)

帕基應用程式

K 號:K220820 · 2022-11-17

決定日期2022-11-17
產品代碼GYD
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

Parky App is the device name listed in this FDA 510(k) record. The listed applicant is H2o Bilisim Yazilim. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K220820. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Parky App?

Parky App is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is H2o Bilisim Yazilim. The 510(k) number is K220820.

When did Parky App receive FDA 510(k) clearance?

Parky App received FDA 510(k) clearance on 2022-11-17, under 510(k) number K220820.

Who is the listed applicant for Parky App?

The FDA 510(k) record lists H2o Bilisim Yazilim as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Parky App?

The FDA product code for Parky App is GYD.

相關臨床試驗

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相關器械(代碼:GYD)

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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