FDA 510(k)

Phasor 钻

K号: K161704 · 2016-12-01

决定日期2016-12-01

产品代码HBE

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决定实质等同

器械摘要

Phasor Drill is the device name listed in this FDA 510(k) record. The listed applicant is Biotex, Inc.. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K161704. 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 Phasor Drill?

Phasor Drill is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Biotex, Inc.. The 510(k) number is K161704.

When did Phasor Drill receive FDA 510(k) clearance?

Phasor Drill received FDA 510(k) clearance on 2016-12-01, under 510(k) number K161704.

Who is the listed applicant for Phasor Drill?

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

What is the FDA product code for Phasor Drill?

The FDA product code for Phasor Drill is HBE.

列明Biotex, 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：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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