FDA 510(k)

Protego空氣水連接器；Protego空氣水瓶管；Protego雙模組管

K 號：K231602 · 2023-08-01

決定日期2023-08-01

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2023-08-01 under 510(k) number K231602. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing?

Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing is a medical device that received FDA 510(k) clearance on 2023-08-01. The listed applicant is Ga Health Company Limited. The 510(k) number is K231602.

When did Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing receive FDA 510(k) clearance?

Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing received FDA 510(k) clearance on 2023-08-01, under 510(k) number K231602.

Who is the listed applicant for Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing?

The FDA product code for Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing is OCX.

其他以 Ga Health Company Limited 為申請人之記錄

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相關器械（代碼：OCX）

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。

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官方來源

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