FDA 510(k)

SonarMed AirWave，呼吸道監測系統

K 號：K143042 · 2016-01-22

決定日期2016-01-22

產品代碼OQU

諮詢委員會AN

決定相當於

器材摘要

SonarMed AirWave, Airway Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Sonarmed, Inc.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K143042. The device is classified under product code OQU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SonarMed AirWave, Airway Monitoring System?

SonarMed AirWave, Airway Monitoring System is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Sonarmed, Inc.. The 510(k) number is K143042.

When did SonarMed AirWave, Airway Monitoring System receive FDA 510(k) clearance?

SonarMed AirWave, Airway Monitoring System received FDA 510(k) clearance on 2016-01-22, under 510(k) number K143042.

Who is the listed applicant for SonarMed AirWave, Airway Monitoring System?

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

What is the FDA product code for SonarMed AirWave, Airway Monitoring System?

The FDA product code for SonarMed AirWave, Airway Monitoring System is OQU.

其他以 Sonarmed, 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。

K193058SonarMed AirWave 呼吸道監測系統

相關器械（代碼：OQU）

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。

K193058SonarMed AirWave 呼吸道監測系統Sonarmed, Inc.

官方來源

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