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FDA 510(k)

鹽酸鹽吸入溶液,3%,3.5%,7%及10%

K 號:K210126 · 2021-12-03

決定日期2021-12-03
產品代碼CAF
諮詢委員會AN
決定相當於

器材摘要

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is the device name listed in this FDA 510(k) record. The listed applicant is The Ritedose Corporation. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K210126. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is The Ritedose Corporation. The 510(k) number is K210126.

When did Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% receive FDA 510(k) clearance?

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% received FDA 510(k) clearance on 2021-12-03, under 510(k) number K210126.

Who is the listed applicant for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

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

What is the FDA product code for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%?

The FDA product code for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% is CAF.

相關臨床試驗

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相關器械(代碼:CAF)

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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