生物波生物包
K 號：K203158 · 2021-07-08
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器材摘要
BioWave BioWraps is the device name listed in this FDA 510(k) record. The listed applicant is Biowave Corporation. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K203158. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BioWave BioWraps?
BioWave BioWraps is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Biowave Corporation. The 510(k) number is K203158.
When did BioWave BioWraps receive FDA 510(k) clearance?
BioWave BioWraps received FDA 510(k) clearance on 2021-07-08, under 510(k) number K203158.
Who is the listed applicant for BioWave BioWraps?
The FDA 510(k) record lists Biowave Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioWave BioWraps?
The FDA product code for BioWave BioWraps is GXY.
相關臨床試驗
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其他以 Biowave Corporation 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：GXY）
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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