EZstim*III 周围神经刺激器/神经定位器
K号: K162048 · 2016-12-05
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决定日期2016-12-05
产品代码KOI
咨询委员会AN
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决定实质等同
器械摘要
EZstim*III Peripheral Nerve Stimulator/Nerve Locator is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health - Irvine. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K162048. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EZstim*III Peripheral Nerve Stimulator/Nerve Locator?
EZstim*III Peripheral Nerve Stimulator/Nerve Locator is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Halyard Health - Irvine. The 510(k) number is K162048.
When did EZstim*III Peripheral Nerve Stimulator/Nerve Locator receive FDA 510(k) clearance?
EZstim*III Peripheral Nerve Stimulator/Nerve Locator received FDA 510(k) clearance on 2016-12-05, under 510(k) number K162048.
Who is the listed applicant for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?
The FDA 510(k) record lists Halyard Health - Irvine as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?
The FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator is KOI.
相关临床试验
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相关器械（代码：KOI）
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
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。
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