FDA 510(k)

納魯神經刺激SCS系統

K 號：K201618 · 2020-07-15

決定日期2020-07-15

產品代碼GZB

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Nalu Neurostimulation SCS 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 2020-07-15 under 510(k) number K201618. 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 SCS system?

Nalu Neurostimulation SCS system is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Boston Scientific Neuromodulation. The 510(k) number is K201618.

When did Nalu Neurostimulation SCS system receive FDA 510(k) clearance?

Nalu Neurostimulation SCS system received FDA 510(k) clearance on 2020-07-15, under 510(k) number K201618.

Who is the listed applicant for Nalu Neurostimulation SCS 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 SCS system?

The FDA product code for Nalu Neurostimulation SCS system is GZB.

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。

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 K232415Nalu神經刺激系統用於週邊神經刺激 K221376納魯神經刺激系統 K203547納魯神經刺激系統 K202274Nalu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。K190960Nalu 領結空白 (50cm)

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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 Neuromodulation K221376納魯神經刺激系統Boston Scientific Neuromodulation K203547納魯神經刺激系統Boston Scientific Neuromodulation K202274Nalu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 Neuromodulation K191466沙灘鯊注射锚釘系統 (SIA)Stimwave Technologies, Inc.K190960Nalu 領結空白 (50cm)Boston Scientific Neuromodulation

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