免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

CoverScan v1

K号: K212565 · 2022-05-19

决定日期2022-05-19
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

CoverScan v1 is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum, Ltd.. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K212565. 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 CoverScan v1?

CoverScan v1 is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Perspectum, Ltd.. The 510(k) number is K212565.

When did CoverScan v1 receive FDA 510(k) clearance?

CoverScan v1 received FDA 510(k) clearance on 2022-05-19, under 510(k) number K212565.

Who is the listed applicant for CoverScan v1?

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

What is the FDA product code for CoverScan v1?

The FDA product code for CoverScan v1 is LLZ.

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。

列明Perspectum, 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。

相关器械(代码:LLZ)

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

在 FDA 数据库中查看 →

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。

↑