納魯神經刺激系統
K 號：K183047 · 2019-03-22
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器材摘要
Nalu Neurostimulation System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K183047. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Nalu Neurostimulation System?
Nalu Neurostimulation System is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Boston Scientific Neuromodulation. The 510(k) number is K183047.
When did Nalu Neurostimulation System receive FDA 510(k) clearance?
Nalu Neurostimulation System received FDA 510(k) clearance on 2019-03-22, under 510(k) number K183047.
Who is the listed applicant for Nalu Neurostimulation System?
The FDA 510(k) record lists Boston Scientific Neuromodulation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nalu Neurostimulation System?
The FDA product code for Nalu Neurostimulation System is GZB.
相關臨床試驗
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其他以 Boston Scientific Neuromodulation 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。
相關器械（代碼：GZB）
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。
K233801Nalu神經刺激系統用於脊髓刺激；Nalu神經刺激系統用於週邊神經刺激Boston Scientific NeuromodulationK221376納魯神經刺激系統Boston Scientific NeuromodulationK203547納魯神經刺激系統Boston Scientific NeuromodulationK202274Nalu神經刺激組合（lnte:gmted 40 em:單一8/雙8），Nalu神經刺激組合（Ported，2 em:單一8/雙8），雙8 Ported Nalu植入手動脈衝發生器，配備40 ern Kil，40 cm/ 60 cm/60 em TrialJExtension Lead Kits，病人組合包和各種備用組合包。Boston Scientific NeuromodulationK201618納魯神經刺激SCS系統Boston Scientific NeuromodulationK191466沙灘鯊注射锚釘系統 (SIA)Stimwave Technologies, Inc.
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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