FDA 510(k)

Hubly電動钻（H100）

K 號：K230619 · 2023-05-04

決定日期2023-05-04

產品代碼HBE

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Hubly, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250815Hubly 閱孔機 (H100)

相關器械（代碼：HBE）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。