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FDA 510(k)

Careverse CoronaryDoc (Careverse CoronaryDoc)

K号: K251656 · 2025-09-04

决定日期2025-09-04
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

Careverse CoronaryDoc (Careverse CoronaryDoc) is the device name listed in this FDA 510(k) record. The listed applicant is Careverse Technology Pte. , Ltd.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251656. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Careverse CoronaryDoc (Careverse CoronaryDoc)?

Careverse CoronaryDoc (Careverse CoronaryDoc) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Careverse Technology Pte. , Ltd.. The 510(k) number is K251656.

When did Careverse CoronaryDoc (Careverse CoronaryDoc) receive FDA 510(k) clearance?

Careverse CoronaryDoc (Careverse CoronaryDoc) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251656.

Who is the listed applicant for Careverse CoronaryDoc (Careverse CoronaryDoc)?

The FDA 510(k) record lists Careverse Technology Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Careverse CoronaryDoc (Careverse CoronaryDoc)?

The FDA product code for Careverse CoronaryDoc (Careverse CoronaryDoc) is QIH.

相关临床试验

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。

相关器械(代码:QIH)

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。

官方来源

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