FDA 510(k)

深度电极，卵圆孔深度电极，Marco-Micro深度电极，Spencer探头深度电极

K号: K163355 · 2017-04-12

申请人Ad-Tech Medical Instrument Corporation

决定日期2017-04-12

产品代码GZL

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决定实质等同

器械摘要

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2017-04-12 under 510(k) number K163355. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K163355.

When did Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes receive FDA 510(k) clearance?

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes received FDA 510(k) clearance on 2017-04-12, under 510(k) number K163355.

Who is the listed applicant for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

The FDA product code for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes is GZL.

列明Ad-Tech Medical Instrument Corporation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。

K223276Anchor Bolts as Accessories to Depth Electrodes K223269Spencer 探头深度电极 K191186硬脑膜条带/术中分裂电极，硬脑膜网格/术中网格电极，双侧半球间硬脑膜电极，多条带和裂隙网格硬脑膜电极，术中映射网格硬脑膜电极 K181544Anchor Bolt (as an accessory to Depth Electrodes)K170442颅骨钻头和附件 K152769FREMAP 电极

查看所有 8 个设备 →

相关器械（代码：GZL）

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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