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FDA 510(k)

Powerpress 康復單位

K 號:K202044 · 2020-10-21

決定日期2020-10-21
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Powerpress Recovery Unit is the device name listed in this FDA 510(k) record. The listed applicant is Hanuri Distribution, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K202044. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Powerpress Recovery Unit?

Powerpress Recovery Unit is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Hanuri Distribution, Inc.. The 510(k) number is K202044.

When did Powerpress Recovery Unit receive FDA 510(k) clearance?

Powerpress Recovery Unit received FDA 510(k) clearance on 2020-10-21, under 510(k) number K202044.

Who is the listed applicant for Powerpress Recovery Unit?

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

What is the FDA product code for Powerpress Recovery Unit?

The FDA product code for Powerpress Recovery Unit is IRP.

相關臨床試驗

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相關器械(代碼:IRP)

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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