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FDA 510(k)

Stimucel 系統、Stimucel 產生器、Stimucel 治療棒、Stimucel 應用器

K 號：K162721 · 2016-12-22

申請人Alliqua Biomedical, Inc.
決定日期2016-12-22
產品代碼NRB
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Alliqua Biomedical, Inc.. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K162721. The device is classified under product code NRB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator?

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Alliqua Biomedical, Inc.. The 510(k) number is K162721.

When did Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator receive FDA 510(k) clearance?

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator received FDA 510(k) clearance on 2016-12-22, under 510(k) number K162721.

Who is the listed applicant for Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator?

The FDA 510(k) record lists Alliqua Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator?

The FDA product code for Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator is NRB.

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Alliqua Biomedical, 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。

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