FDA 510(k)

Katalyst Mark 1 肌肉刺激系统型号2

K号: K181199 · 2018-09-20

决定日期2018-09-20

产品代码NGX

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决定实质等同

器械摘要

Katalyst Mark 1 Muscle Stimulation System Model 2 is the device name listed in this FDA 510(k) record. The listed applicant is Katalyst, Inc.. It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K181199. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Katalyst Mark 1 Muscle Stimulation System Model 2?

Katalyst Mark 1 Muscle Stimulation System Model 2 is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Katalyst, Inc.. The 510(k) number is K181199.

When did Katalyst Mark 1 Muscle Stimulation System Model 2 receive FDA 510(k) clearance?

Katalyst Mark 1 Muscle Stimulation System Model 2 received FDA 510(k) clearance on 2018-09-20, under 510(k) number K181199.

Who is the listed applicant for Katalyst Mark 1 Muscle Stimulation System Model 2?

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

What is the FDA product code for Katalyst Mark 1 Muscle Stimulation System Model 2?

The FDA product code for Katalyst Mark 1 Muscle Stimulation System Model 2 is NGX.

列明Katalyst, Inc.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。

K190966Katalyst训练系统 K171035Katalyst Mark 1 肌肉刺激系统

官方来源

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