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FDA 510(k)

Mobility+ 飲食輔助系統 非處方藥

K 號:K233034 · 2024-04-12

決定日期2024-04-12
產品代碼PIF
諮詢委員會GU
決定相當於

器材摘要

Mobility+ Enteral Feeding System OTC is the device name listed in this FDA 510(k) record. The listed applicant is Rockfield Medical. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K233034. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mobility+ Enteral Feeding System OTC?

Mobility+ Enteral Feeding System OTC is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Rockfield Medical. The 510(k) number is K233034.

When did Mobility+ Enteral Feeding System OTC receive FDA 510(k) clearance?

Mobility+ Enteral Feeding System OTC received FDA 510(k) clearance on 2024-04-12, under 510(k) number K233034.

Who is the listed applicant for Mobility+ Enteral Feeding System OTC?

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

What is the FDA product code for Mobility+ Enteral Feeding System OTC?

The FDA product code for Mobility+ Enteral Feeding System OTC is PIF.

相關臨床試驗

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。

其他以 Rockfield Medical 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:PIF)

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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