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)

EzDent-i / E2 / Prora View/ Smart M Viewer

K号: K223820 · 2023-02-17

决定日期2023-02-17
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

EzDent-i / E2 / Prora View/ Smart M Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K223820. 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 EzDent-i / E2 / Prora View/ Smart M Viewer?

EzDent-i / E2 / Prora View/ Smart M Viewer is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K223820.

When did EzDent-i / E2 / Prora View/ Smart M Viewer receive FDA 510(k) clearance?

EzDent-i / E2 / Prora View/ Smart M Viewer received FDA 510(k) clearance on 2023-02-17, under 510(k) number K223820.

Who is the listed applicant for EzDent-i / E2 / Prora View/ Smart M Viewer?

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

What is the FDA product code for EzDent-i / E2 / Prora View/ Smart M Viewer?

The FDA product code for EzDent-i / E2 / Prora View/ Smart M Viewer 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Ewoosoft Co., 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。

查看所有 27 个设备 →

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。

↑