FDA 510(k)

deepLive（OSP12 + DMS）

K号: K252851 · 2025-10-07

决定日期2025-10-07

产品代码NQQ

咨询委员会RA

决定实质等同

器械摘要

deepLive (OSP12 + DMS) is the device name listed in this FDA 510(k) record. The listed applicant is Damae Medical. It received FDA 510(k) clearance on 2025-10-07 under 510(k) number K252851. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the deepLive (OSP12 + DMS)?

deepLive (OSP12 + DMS) is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Damae Medical. The 510(k) number is K252851.

When did deepLive (OSP12 + DMS) receive FDA 510(k) clearance?

deepLive (OSP12 + DMS) received FDA 510(k) clearance on 2025-10-07, under 510(k) number K252851.

Who is the listed applicant for deepLive (OSP12 + DMS)?

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

What is the FDA product code for deepLive (OSP12 + DMS)?

The FDA product code for deepLive (OSP12 + DMS) is NQQ.

列明Damae Medical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。

K240610deepLive

官方来源

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