導航器（FMNVG15）；導航器XL（FMNVX06）
K 號：K240105 · 2024-08-29
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器材摘要
Navigator (FMNVG15); Navigator XL (FMNVX06) is the device name listed in this FDA 510(k) record. The listed applicant is Forcemech International, LLC. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K240105. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Navigator (FMNVG15); Navigator XL (FMNVX06)?
Navigator (FMNVG15); Navigator XL (FMNVX06) is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Forcemech International, LLC. The 510(k) number is K240105.
When did Navigator (FMNVG15); Navigator XL (FMNVX06) receive FDA 510(k) clearance?
Navigator (FMNVG15); Navigator XL (FMNVX06) received FDA 510(k) clearance on 2024-08-29, under 510(k) number K240105.
Who is the listed applicant for Navigator (FMNVG15); Navigator XL (FMNVX06)?
The FDA 510(k) record lists Forcemech International, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Navigator (FMNVG15); Navigator XL (FMNVX06)?
The FDA product code for Navigator (FMNVG15); Navigator XL (FMNVX06) is ITI.
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。
相關器械（代碼：ITI）
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
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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