geko™ W-2
K 號：K193045 · 2020-01-18
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器材摘要
geko™ W-2 is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2020-01-18 under 510(k) number K193045. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the geko™ W-2?
geko™ W-2 is a medical device that received FDA 510(k) clearance on 2020-01-18. The listed applicant is Firstkind Limited. The 510(k) number is K193045.
When did geko™ W-2 receive FDA 510(k) clearance?
geko™ W-2 received FDA 510(k) clearance on 2020-01-18, under 510(k) number K193045.
Who is the listed applicant for geko™ W-2?
The FDA 510(k) record lists Firstkind Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for geko™ W-2?
The FDA product code for geko™ W-2 is IPF.
其他以 Firstkind Limited 為申請人之記錄
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相關器械（代碼：IPF）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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