RP Lite 760R
K 號：K163280 · 2017-01-27
廣告
器材摘要
RP Lite 760R is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek AC , Ltd.. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K163280. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RP Lite 760R?
RP Lite 760R is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Mego Afek AC , Ltd.. The 510(k) number is K163280.
When did RP Lite 760R receive FDA 510(k) clearance?
RP Lite 760R received FDA 510(k) clearance on 2017-01-27, under 510(k) number K163280.
Who is the listed applicant for RP Lite 760R?
The FDA 510(k) record lists Mego Afek AC , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RP Lite 760R?
The FDA product code for RP Lite 760R is IRP.
其他以 Mego Afek AC , 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。
相關器械（代碼：IRP）
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。
K260944瑪娜冷壓系統Manamed, LLCK260529空壓按摩器（HY-1165）Xiamen High Top Electronic Technology Co., Ltd.K260948空壓按摩器（EP30B001 I）Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919冷熱療法系統Xiamen Weiyou Intelligent Technology Co., Ltd.K252396冷凍運動2.0（AVA 501）Avanutri Equipamentos DE SaúdeK254200空气压缩腿部按摩器（LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14）Wenzhou Lingfeng Electronic Technology Co., Ltd.
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