JAS Pulse™ 超音波治療器
K 號：K161628 · 2016-11-10
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器材摘要
JAS Pulse(TM) Ultrasonic Therapy is the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research, Inc.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K161628. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the JAS Pulse(TM) Ultrasonic Therapy?
JAS Pulse(TM) Ultrasonic Therapy is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K161628.
When did JAS Pulse(TM) Ultrasonic Therapy receive FDA 510(k) clearance?
JAS Pulse(TM) Ultrasonic Therapy received FDA 510(k) clearance on 2016-11-10, under 510(k) number K161628.
Who is the listed applicant for JAS Pulse(TM) Ultrasonic Therapy?
The FDA 510(k) record lists Bonutti Research, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for JAS Pulse(TM) Ultrasonic Therapy?
The FDA product code for JAS Pulse(TM) Ultrasonic Therapy is IMI.
相關臨床試驗
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相關器械（代碼：IMI）
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。
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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