7 Series 光療設備
K 號：K212510 · 2021-11-04
廣告
器材摘要
7 Series Phototherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K212510. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 7 Series Phototherapy Device?
7 Series Phototherapy Device is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K212510.
When did 7 Series Phototherapy Device receive FDA 510(k) clearance?
7 Series Phototherapy Device received FDA 510(k) clearance on 2021-11-04, under 510(k) number K212510.
Who is the listed applicant for 7 Series Phototherapy Device?
The FDA 510(k) record lists Daavlin Distributing Co. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 7 Series Phototherapy Device?
The FDA product code for 7 Series Phototherapy Device is FTC.
相關臨床試驗
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。
其他以 Daavlin Distributing Co. 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：FTC）
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。
K254234光療系統（DUV-COMBO）Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425紫外光療法設備APK Technology Co., Ltd.K244022308nm 紫外光光療系統 (UV-K)；308nm 紫外光光療系統 (UV-X)；308nm 紫外光光療系統 (UV-Y)；308nm 紫外光光療系統 (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer光療設備（CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K）Xuzhou Kernel Medical Equipment Co., Ltd.K242908紫外光療法設備（分組A：SQ308PCHFD、SQ308PCQFD、SQ308PCPFD、SQ308PCNFD、SQ308PCMFD）；紫外光療法設備（分組B：SQ308PHTFF、SQ308PHSFF、SQ308PHRFF、SQ308PHZFG、SQ308PPUFF、SQ308PPVFF、SQ308PPWFG）Shanghai Sigma High-Tech 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