FDA 510(k)

日本光電 NKV-550 系列呼吸器系統

K 號：K181695 · 2018-12-07

決定日期2018-12-07

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

Nihon Kohden NKV-550 Series Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Orangemed, Inc.. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K181695. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nihon Kohden NKV-550 Series Ventilator System?

Nihon Kohden NKV-550 Series Ventilator System is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Nihon Kohden Orangemed, Inc.. The 510(k) number is K181695.

When did Nihon Kohden NKV-550 Series Ventilator System receive FDA 510(k) clearance?

Nihon Kohden NKV-550 Series Ventilator System received FDA 510(k) clearance on 2018-12-07, under 510(k) number K181695.

Who is the listed applicant for Nihon Kohden NKV-550 Series Ventilator System?

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

What is the FDA product code for Nihon Kohden NKV-550 Series Ventilator System?

The FDA product code for Nihon Kohden NKV-550 Series Ventilator System is CBK.

其他以 Nihon Kohden Orangemed, 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。

K222644日本光電 NKV-440 呼吸器系統 K213521日本光電 NKV-330 呼吸器系統 K192307日本光電 NKV-550 系列呼吸器系統

相關器械（代碼：CBK）

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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