免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

最佳內科應用器

K 號：K162499 · 2018-04-13

申請人Best Medical International, Inc.
決定日期2018-04-13
產品代碼JAQ
諮詢委員會RA
決定相當於

器材摘要

Best Instruminal Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Best Medical International, Inc.. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K162499. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Best Instruminal Applicator?

Best Instruminal Applicator is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Best Medical International, Inc.. The 510(k) number is K162499.

When did Best Instruminal Applicator receive FDA 510(k) clearance?

Best Instruminal Applicator received FDA 510(k) clearance on 2018-04-13, under 510(k) number K162499.

Who is the listed applicant for Best Instruminal Applicator?

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

What is the FDA product code for Best Instruminal Applicator?

The FDA product code for Best Instruminal Applicator is JAQ.

相關臨床試驗

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。

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

相關器械（代碼：JAQ）

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。

K262383LumenCare 銀河Nucletron B.V.K252717MAASTRO 直腸施藥器組Varian Medical SystemsK251037直腸施藥器Nucletron B.V.K252884導向阿魯斯應用器組Varian Medical SystemsK250299CT/ MR 串聯及卵形組合Varian Medical Systems, Inc.K250289內腔/間質系統Varian Medical Systems

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。

↑