FDA 510(k)

X-100C CO-Met™ 血氧儀系統

K 號：K160231 · 2016-12-23

決定日期2016-12-23

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Model X-100C CO-Met™ Oximetry System is the device name listed in this FDA 510(k) record. The listed applicant is Nonin Medical, Inc.. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K160231. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Model X-100C CO-Met™ Oximetry System?

Model X-100C CO-Met™ Oximetry System is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K160231.

When did Model X-100C CO-Met™ Oximetry System receive FDA 510(k) clearance?

Model X-100C CO-Met™ Oximetry System received FDA 510(k) clearance on 2016-12-23, under 510(k) number K160231.

Who is the listed applicant for Model X-100C CO-Met™ Oximetry System?

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

What is the FDA product code for Model X-100C CO-Met™ Oximetry System?

The FDA product code for Model X-100C CO-Met™ Oximetry System is DQA.

其他以 Nonin Medical, Inc. 為申請人之記錄

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相關器械（代碼：DQA）

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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