FDA 510(k)

颅骨钻头和附件

K号: K170442 · 2017-09-07

申请人Ad-Tech Medical Instrument Corporation

决定日期2017-09-07

产品代码HBE

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Cranial Drill Bits and Accessories 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 2017-09-07 under 510(k) number K170442. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cranial Drill Bits and Accessories?

Cranial Drill Bits and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K170442.

When did Cranial Drill Bits and Accessories receive FDA 510(k) clearance?

Cranial Drill Bits and Accessories received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170442.

Who is the listed applicant for Cranial Drill Bits and Accessories?

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 Cranial Drill Bits and Accessories?

The FDA product code for Cranial Drill Bits and Accessories is HBE.

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)K163355深度电极，卵圆孔深度电极，Marco-Micro深度电极，Spencer探头深度电极 K152769FREMAP 电极

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相关器械（代码：HBE）

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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