FDA 510(k)

Annalise 企业 CTB 三级创伤

K号: K231384 · 2023-09-22

决定日期2023-09-22

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

Annalise Enterprise CTB Triage Trauma is the device name listed in this FDA 510(k) record. The listed applicant is Annalise-Ai Pty , Ltd.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231384. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Annalise Enterprise CTB Triage Trauma?

Annalise Enterprise CTB Triage Trauma is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Annalise-Ai Pty , Ltd.. The 510(k) number is K231384.

When did Annalise Enterprise CTB Triage Trauma receive FDA 510(k) clearance?

Annalise Enterprise CTB Triage Trauma received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231384.

Who is the listed applicant for Annalise Enterprise CTB Triage Trauma?

The FDA 510(k) record lists Annalise-Ai Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Annalise Enterprise CTB Triage Trauma?

The FDA product code for Annalise Enterprise CTB Triage Trauma is QAS.

列明Annalise-Ai Pty , Ltd.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。

K231767Annalise 企业 CTB 三级创伤 K231094Annalise 企业 CTB 三级创伤-OH K223240Annalise 企业 CTB 三级创伤 K222179Annalise 企业 CXR 三级创伤 K222268Annalise 企业 CXR 三级创伤

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。