FDA 510(k)

hekaDrill

K号: K193630 · 2021-04-09

决定日期2021-04-09

产品代码HBC

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决定实质等同

器械摘要

hekaDrill is the device name listed in this FDA 510(k) record. The listed applicant is Zethon, Ltd.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K193630. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the hekaDrill?

hekaDrill is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Zethon, Ltd.. The 510(k) number is K193630.

When did hekaDrill receive FDA 510(k) clearance?

hekaDrill received FDA 510(k) clearance on 2021-04-09, under 510(k) number K193630.

Who is the listed applicant for hekaDrill?

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

What is the FDA product code for hekaDrill?

The FDA product code for hekaDrill is HBC.

列明Zethon, Ltd.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。

K233958hekaDrill

官方来源

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