FDA 510(k)

Hubly 电动钻（H100）

K号: K230619 · 2023-05-04

决定日期2023-05-04

产品代码HBE

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决定实质等同

器械摘要

Hubly Electric Drill (H100) is the device name listed in this FDA 510(k) record. The listed applicant is Hubly, Inc.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K230619. 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 Hubly Electric Drill (H100)?

Hubly Electric Drill (H100) is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Hubly, Inc.. The 510(k) number is K230619.

When did Hubly Electric Drill (H100) receive FDA 510(k) clearance?

Hubly Electric Drill (H100) received FDA 510(k) clearance on 2023-05-04, under 510(k) number K230619.

Who is the listed applicant for Hubly Electric Drill (H100)?

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

What is the FDA product code for Hubly Electric Drill (H100)?

The FDA product code for Hubly Electric Drill (H100) is HBE.

列明Hubly, 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。

K250815Hubly 钻头（H100）

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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