FDA 510(k)

SonarMed AirWave 呼吸道监测系统

K号: K193058 · 2020-05-15

决定日期2020-05-15

产品代码OQU

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决定实质等同

器械摘要

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 2020-05-15 under 510(k) number K193058. The device is classified under product code OQU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SonarMed AirWave Airway Monitoring System?

SonarMed AirWave Airway Monitoring System is a medical device that received FDA 510(k) clearance on 2020-05-15. The listed applicant is Sonarmed, Inc.. The 510(k) number is K193058.

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

SonarMed AirWave Airway Monitoring System received FDA 510(k) clearance on 2020-05-15, under 510(k) number K193058.

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.

列明Sonarmed, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K143042SonarMed AirWave，呼吸道监测系统

官方来源

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