FDA 510(k)

實驗室袋配布料口袋

K 號：K210248 · 2021-07-30

決定日期2021-07-30

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Lab Bag with Fabric Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Design Co., Ltd.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K210248. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lab Bag with Fabric Pouch?

Lab Bag with Fabric Pouch is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Advanced Medical Design Co., Ltd.. The 510(k) number is K210248.

When did Lab Bag with Fabric Pouch receive FDA 510(k) clearance?

Lab Bag with Fabric Pouch received FDA 510(k) clearance on 2021-07-30, under 510(k) number K210248.

Who is the listed applicant for Lab Bag with Fabric Pouch?

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

What is the FDA product code for Lab Bag with Fabric Pouch?

The FDA product code for Lab Bag with Fabric Pouch is GCJ.

其他以 Advanced Medical Design 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。

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相關器械（代碼：GCJ）

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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