FDA 510(k)

Velocity Alpha 高速外科钻削系统

K号: K191479 · 2021-04-11

决定日期2021-04-11

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

Velocity Alpha Highspeed Surgical Drill System is the device name listed in this FDA 510(k) record. The listed applicant is Adeor Medical AG. It received FDA 510(k) clearance on 2021-04-11 under 510(k) number K191479. 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 Velocity Alpha Highspeed Surgical Drill System?

Velocity Alpha Highspeed Surgical Drill System is a medical device that received FDA 510(k) clearance on 2021-04-11. The listed applicant is Adeor Medical AG. The 510(k) number is K191479.

When did Velocity Alpha Highspeed Surgical Drill System receive FDA 510(k) clearance?

Velocity Alpha Highspeed Surgical Drill System received FDA 510(k) clearance on 2021-04-11, under 510(k) number K191479.

Who is the listed applicant for Velocity Alpha Highspeed Surgical Drill System?

The FDA 510(k) record lists Adeor Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velocity Alpha Highspeed Surgical Drill System?

The FDA product code for Velocity Alpha Highspeed Surgical Drill System is HBE.

列明Adeor Medical AG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。

K253772Velocity Alpha 高速手术钻系统 K191847Adeor医疗nxt非粘性双极镊子，Adeor医疗nxt一次性非粘性双极镊子

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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