IllumiFlow 激光帽
K 號：K162071 · 2017-02-24
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器材摘要
IllumiFlow Laser Cap is the device name listed in this FDA 510(k) record. The listed applicant is Eglobal, LLC. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162071. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the IllumiFlow Laser Cap?
IllumiFlow Laser Cap is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Eglobal, LLC. The 510(k) number is K162071.
When did IllumiFlow Laser Cap receive FDA 510(k) clearance?
IllumiFlow Laser Cap received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162071.
Who is the listed applicant for IllumiFlow Laser Cap?
The FDA 510(k) record lists Eglobal, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IllumiFlow Laser Cap?
The FDA product code for IllumiFlow Laser Cap is OAP.
相關臨床試驗
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其他以 Eglobal, LLC 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：OAP）
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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