geko T-2 及 geko Plus R-2
K 號：K180082 · 2018-02-11
廣告
器材摘要
geko T-2 and geko Plus R-2 is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind, Ltd.. It received FDA 510(k) clearance on 2018-02-11 under 510(k) number K180082. 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 T-2 and geko Plus R-2?
geko T-2 and geko Plus R-2 is a medical device that received FDA 510(k) clearance on 2018-02-11. The listed applicant is Firstkind, Ltd.. The 510(k) number is K180082.
When did geko T-2 and geko Plus R-2 receive FDA 510(k) clearance?
geko T-2 and geko Plus R-2 received FDA 510(k) clearance on 2018-02-11, under 510(k) number K180082.
Who is the listed applicant for geko T-2 and geko Plus R-2?
The FDA 510(k) record lists Firstkind, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for geko T-2 and geko Plus R-2?
The FDA product code for geko T-2 and geko Plus R-2 is IPF.
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。
廣告