Sonendo柔波系統
K 號：K160905 · 2016-06-03
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器材摘要
Sonendo GentleWave System is the device name listed in this FDA 510(k) record. The listed applicant is Sonendo, Inc.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K160905. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sonendo GentleWave System?
Sonendo GentleWave System is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Sonendo, Inc.. The 510(k) number is K160905.
When did Sonendo GentleWave System receive FDA 510(k) clearance?
Sonendo GentleWave System received FDA 510(k) clearance on 2016-06-03, under 510(k) number K160905.
Who is the listed applicant for Sonendo GentleWave System?
The FDA 510(k) record lists Sonendo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sonendo GentleWave System?
The FDA product code for Sonendo GentleWave System is ELC.
相關臨床試驗
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其他以 Sonendo, 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：ELC）
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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