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)

NP醫療nCompass擴充組合配穩定底座

K 號：K221518 · 2022-11-03

申請人Np Medical
決定日期2022-11-03
產品代碼FPA
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

NP Medical nCompass Extension Set with Stabilizing Base is the device name listed in this FDA 510(k) record. The listed applicant is Np Medical. It received FDA 510(k) clearance on 2022-11-03 under 510(k) number K221518. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NP Medical nCompass Extension Set with Stabilizing Base?

NP Medical nCompass Extension Set with Stabilizing Base is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Np Medical. The 510(k) number is K221518.

When did NP Medical nCompass Extension Set with Stabilizing Base receive FDA 510(k) clearance?

NP Medical nCompass Extension Set with Stabilizing Base received FDA 510(k) clearance on 2022-11-03, under 510(k) number K221518.

Who is the listed applicant for NP Medical nCompass Extension Set with Stabilizing Base?

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

What is the FDA product code for NP Medical nCompass Extension Set with Stabilizing Base?

The FDA product code for NP Medical nCompass Extension Set with Stabilizing Base is FPA.

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

其他以 Np Medical 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。

K251257nSet+ 稳定組 [6426733]; nSet+ 稳定組搭配 nSyte 非針刺連接器 (NFC) [6426731]; nSyte 非針刺連接器 (NFC) [6426727]

相關器械（代碼：FPA）

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。

K254123Ecomed 一次性注射用藥物輸注套件Ecomed Solutions, LLCK261530iiSure 靜脈輸注套件Deka Research and DevelopmentK252543AMSafe 藥物輸注套件 (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath 火飛無針連接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定組 [6426733]; nSet+ 稳定組搭配 nSyte 非針刺連接器 (NFC) [6426731]; nSyte 非針刺連接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵輸注套件Carefusion (Bd)

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。

↑