FDA 510(k)CP緩解棒-OTC
K 號:K162630 · 2016-12-20
決定日期2016-12-20
產品代碼NUH
諮詢委員會NE
(請提供完整的英文描述,以便進行翻譯。)
決定相當於
器材摘要
CP Relief Wand-OTC is the device name listed in this FDA 510(k) record. The listed applicant is Mid-America Medical Innovations, LLC. It received FDA 510(k) clearance on 2016-12-20 under 510(k) number K162630. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CP Relief Wand-OTC?
CP Relief Wand-OTC is a medical device that received FDA 510(k) clearance on 2016-12-20. The listed applicant is Mid-America Medical Innovations, LLC. The 510(k) number is K162630.
When did CP Relief Wand-OTC receive FDA 510(k) clearance?
CP Relief Wand-OTC received FDA 510(k) clearance on 2016-12-20, under 510(k) number K162630.
Who is the listed applicant for CP Relief Wand-OTC?
The FDA 510(k) record lists Mid-America Medical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CP Relief Wand-OTC?
The FDA product code for CP Relief Wand-OTC is NUH.
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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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