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FDA 510(k)

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

K号: K153045 · 2016-05-13

决定日期2016-05-13
产品代码BXN
咨询委员会AN 请注意,由于您没有提供完整的医疗设备监管文本,我无法提供完整的翻译。如果您能提供完整的文本,我将很乐意为您翻译。
决定实质等同

器械摘要

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Easy Med Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K153045. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Easy Med Instrument Co., Ltd.. The 510(k) number is K153045.

When did SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator receive FDA 510(k) clearance?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator received FDA 510(k) clearance on 2016-05-13, under 510(k) number K153045.

Who is the listed applicant for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

The FDA 510(k) record lists Easy Med Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

The FDA product code for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is BXN.

相关临床试验

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。

相关器械(代码:BXN)

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。

官方来源

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