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FDA 510(k)

NvisionVLE 影像控制台，NvisionVLE 標記探針，20mm 气球，NvisionVLE 標記探針，17mm 气球，NvisionVLE 標記探針，14mm 气球，NvisionVLE 膨脹系統

K 號：K153479 · 2016-02-16

申請人Ninepoint Medical, Inc.
決定日期2016-02-16
產品代碼NQQ
諮詢委員會RA
決定Unknown

器材摘要

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System is the device name listed in this FDA 510(k) record. The listed applicant is Ninepoint Medical, Inc.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153479. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

常見問題

What is the NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System?

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Ninepoint Medical, Inc.. The 510(k) number is K153479.

When did NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System receive FDA 510(k) clearance?

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153479.

Who is the listed applicant for NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System?

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

What is the FDA product code for NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System?

The FDA product code for NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System is NQQ.

相關臨床試驗

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其他以 Ninepoint Medical, Inc. 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。

K191117NvisionVLE 低配置光學探針K182616NvisionVLE影像系統，NvisionVLE光學探針，NvisionVLE充氣系統K182261NvisionVLE影像系統，NvisionVLE光學探針

相關器械（代碼：NQQ）

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

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