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)

OTOPLAN

K号: K242120 · 2025-04-11

决定日期2025-04-11
产品代码QQE
咨询委员会RA
决定实质等同

器械摘要

OTOPLAN is the device name listed in this FDA 510(k) record. The listed applicant is Cascination AG. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242120. The device is classified under product code QQE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OTOPLAN?

OTOPLAN is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Cascination AG. The 510(k) number is K242120.

When did OTOPLAN receive FDA 510(k) clearance?

OTOPLAN received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242120.

Who is the listed applicant for OTOPLAN?

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

What is the FDA product code for OTOPLAN?

The FDA product code for OTOPLAN is QQE.

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Cascination AG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:QQE)

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。

↑