FDA 510(k)

MY01 连续隔室压力监测仪

K号: K193321 · 2020-07-30

决定日期2020-07-30

产品代码LXC

决定实质等同

器械摘要

MY01 Continuous Compartmental Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is MY01, Inc.. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K193321. The device is classified under product code LXC. FDA Decision: Substantially Equivalent.

常见问题

What is the MY01 Continuous Compartmental Pressure Monitor?

MY01 Continuous Compartmental Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is MY01, Inc.. The 510(k) number is K193321.

When did MY01 Continuous Compartmental Pressure Monitor receive FDA 510(k) clearance?

MY01 Continuous Compartmental Pressure Monitor received FDA 510(k) clearance on 2020-07-30, under 510(k) number K193321.

Who is the listed applicant for MY01 Continuous Compartmental Pressure Monitor?

The FDA 510(k) record lists MY01, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MY01 Continuous Compartmental Pressure Monitor?

The FDA product code for MY01 Continuous Compartmental Pressure Monitor is LXC.

列明MY01, 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。

K251900MY01 连续隔室压力监测仪 K242997MY01 连续隔室压力监测仪 K220952MY01 连续隔室压力监测仪 K210525MY01 连续隔室压力监测仪 K202635MY01 连续隔室压力监测仪

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。