FDA 510(k)

eXciteOSA无遥控器版（3000）；eXciteOSA带遥控器版（6000）

K号: K240328 · 2024-05-16

决定日期2024-05-16

产品代码QNO

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决定实质等同

器械摘要

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is the device name listed in this FDA 510(k) record. The listed applicant is Signifier Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K240328. The device is classified under product code QNO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Signifier Medical Technologies, Ltd.. The 510(k) number is K240328.

When did eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) receive FDA 510(k) clearance?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) received FDA 510(k) clearance on 2024-05-16, under 510(k) number K240328.

Who is the listed applicant for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

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

What is the FDA product code for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

The FDA product code for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is QNO.

列明Signifier Medical Technologies, 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。

K223446eXciteOSA无遥控器版（3000）；eXciteOSA带遥控器版（6000）

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。