miraDry 系統
K 號：K160141 · 2016-10-31
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器材摘要
miraDry System is the device name listed in this FDA 510(k) record. The listed applicant is Miramar Labs, Inc.. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K160141. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the miraDry System?
miraDry System is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Miramar Labs, Inc.. The 510(k) number is K160141.
When did miraDry System receive FDA 510(k) clearance?
miraDry System received FDA 510(k) clearance on 2016-10-31, under 510(k) number K160141.
Who is the listed applicant for miraDry System?
The FDA 510(k) record lists Miramar Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for miraDry System?
The FDA product code for miraDry System is NEY.
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 Miramar Labs, Inc. 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：NEY）
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
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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