RENASYS GO
K 號：K152163 · 2016-09-29
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器材摘要
RENASYS GO is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K152163. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RENASYS GO?
RENASYS GO is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K152163.
When did RENASYS GO receive FDA 510(k) clearance?
RENASYS GO received FDA 510(k) clearance on 2016-09-29, under 510(k) number K152163.
Who is the listed applicant for RENASYS GO?
The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RENASYS GO?
The FDA product code for RENASYS GO is OMP.
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其他以 Smith & Nephew, Inc. 為申請人之記錄
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相關器械（代碼：OMP）
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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