FDA 510(k)

磁手术系统

K号: K250746 · 2025-06-07

决定日期2025-06-07

产品代码PNL

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决定实质等同

器械摘要

Magnetic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Levita Magnetics International Corp. It received FDA 510(k) clearance on 2025-06-07 under 510(k) number K250746. The device is classified under product code PNL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Magnetic Surgical System?

Magnetic Surgical System is a medical device that received FDA 510(k) clearance on 2025-06-07. The listed applicant is Levita Magnetics International Corp. The 510(k) number is K250746.

When did Magnetic Surgical System receive FDA 510(k) clearance?

Magnetic Surgical System received FDA 510(k) clearance on 2025-06-07, under 510(k) number K250746.

Who is the listed applicant for Magnetic Surgical System?

The FDA 510(k) record lists Levita Magnetics International Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Magnetic Surgical System?

The FDA product code for Magnetic Surgical System is PNL.

列明Levita Magnetics International Corp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。

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官方来源

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