FDA 510(k)

EARP 神经袖套电极

K号: K230853 · 2023-10-06

申请人Nvision Biomedical Technologies, Inc.

决定日期2023-10-06

产品代码ETN

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决定实质等同

器械摘要

EARP Nerve Cuff Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K230853. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EARP Nerve Cuff Electrode?

EARP Nerve Cuff Electrode is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K230853.

When did EARP Nerve Cuff Electrode receive FDA 510(k) clearance?

EARP Nerve Cuff Electrode received FDA 510(k) clearance on 2023-10-06, under 510(k) number K230853.

Who is the listed applicant for EARP Nerve Cuff Electrode?

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

What is the FDA product code for EARP Nerve Cuff Electrode?

The FDA product code for EARP Nerve Cuff Electrode is ETN.

列明Nvision Biomedical Technologies, 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。

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相关器械（代码：ETN）

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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