FDA 510(k)

Ascent 心肺诊断软件

K号: K181912 · 2019-04-12

决定日期2019-04-12

产品代码BTY

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决定实质等同

器械摘要

Ascent Cardiorespiratory Diagnostic Software is the device name listed in this FDA 510(k) record. The listed applicant is Medical Graphics Corporation. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K181912. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ascent Cardiorespiratory Diagnostic Software?

Ascent Cardiorespiratory Diagnostic Software is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Medical Graphics Corporation. The 510(k) number is K181912.

When did Ascent Cardiorespiratory Diagnostic Software receive FDA 510(k) clearance?

Ascent Cardiorespiratory Diagnostic Software received FDA 510(k) clearance on 2019-04-12, under 510(k) number K181912.

Who is the listed applicant for Ascent Cardiorespiratory Diagnostic Software?

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

What is the FDA product code for Ascent Cardiorespiratory Diagnostic Software?

The FDA product code for Ascent Cardiorespiratory Diagnostic Software is BTY.

列明Medical Graphics Corporation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。

K242809Ascent 心肺诊断软件

官方来源

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