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FDA 510(k)

Air Relax

K 號:K173158 · 2019-05-30

決定日期2019-05-30
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Air Relax is the device name listed in this FDA 510(k) record. The listed applicant is Maxstar Industrial Co., Ltd.. It received FDA 510(k) clearance on 2019-05-30 under 510(k) number K173158. 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 Air Relax?

Air Relax is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Maxstar Industrial Co., Ltd.. The 510(k) number is K173158.

When did Air Relax receive FDA 510(k) clearance?

Air Relax received FDA 510(k) clearance on 2019-05-30, under 510(k) number K173158.

Who is the listed applicant for Air Relax?

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

What is the FDA product code for Air Relax?

The FDA product code for Air Relax is IRP.

相關臨床試驗

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其他以 Maxstar Industrial Co., Ltd. 為申請人之記錄

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。

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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