FDA 510(k)

Annalise 企业 CTB 三级创伤-OH

K号: K231094 · 2023-08-15

决定日期2023-08-15

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-OH 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 2023-08-15 under 510(k) number K231094. 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-OH?

Annalise Enterprise CTB Triage-OH is a medical device that received FDA 510(k) clearance on 2023-08-15. The listed applicant is Annalise-Ai Pty , Ltd.. The 510(k) number is K231094.

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

Annalise Enterprise CTB Triage-OH received FDA 510(k) clearance on 2023-08-15, under 510(k) number K231094.

Who is the listed applicant for Annalise Enterprise CTB Triage-OH?

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-OH?

The FDA product code for Annalise Enterprise CTB Triage-OH 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 K231384Annalise 企业 CTB 三级创伤 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。