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FDA 510(k)

SONIK MONARK 100

K号: K234036 · 2024-02-15

决定日期2024-02-15
产品代码LXM
决定实质等同

器械摘要

SONIK MONARK 100 is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Spinal Innovation, Inc.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K234036. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

常见问题

What is the SONIK MONARK 100?

SONIK MONARK 100 is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Neuro Spinal Innovation, Inc.. The 510(k) number is K234036.

When did SONIK MONARK 100 receive FDA 510(k) clearance?

SONIK MONARK 100 received FDA 510(k) clearance on 2024-02-15, under 510(k) number K234036.

Who is the listed applicant for SONIK MONARK 100?

The FDA 510(k) record lists Neuro Spinal Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONIK MONARK 100?

The FDA product code for SONIK MONARK 100 is LXM.

相关临床试验

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相关器械(代码:LXM)

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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