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FDA 510(k)

NXPRO 神經肌肉電刺激設備

K 號:K191181 · 2019-10-11

決定日期2019-10-11
產品代碼NGX
諮詢委員會PM
決定相當於

器材摘要

NXPRO Neuromuscular Electrical Stimulation Device is the device name listed in this FDA 510(k) record. The listed applicant is Neux Technologies, Inc.. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191181. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NXPRO Neuromuscular Electrical Stimulation Device?

NXPRO Neuromuscular Electrical Stimulation Device is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Neux Technologies, Inc.. The 510(k) number is K191181.

When did NXPRO Neuromuscular Electrical Stimulation Device receive FDA 510(k) clearance?

NXPRO Neuromuscular Electrical Stimulation Device received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191181.

Who is the listed applicant for NXPRO Neuromuscular Electrical Stimulation Device?

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

What is the FDA product code for NXPRO Neuromuscular Electrical Stimulation Device?

The FDA product code for NXPRO Neuromuscular Electrical Stimulation Device is NGX.

相關臨床試驗

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相關器械(代碼:NGX)

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。

官方來源

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