FDA 510(k)

CommandEP 数据管理器 PC (DPC02), CommandEP HMD (HMD02)

K号: K223290 · 2023-07-14

决定日期2023-07-14

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is the device name listed in this FDA 510(k) record. The listed applicant is Sentiar, Inc.. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K223290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Sentiar, Inc.. The 510(k) number is K223290.

When did CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) receive FDA 510(k) clearance?

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K223290.

Who is the listed applicant for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

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

What is the FDA product code for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)?

The FDA product code for CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) is LLZ.

列明Sentiar, 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。

K192890SentEP

官方来源

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