FDA 510(k)

HBL刀片組裝

K 號：K222490 · 2022-11-14

決定日期2022-11-14

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

HBL Blade Assembly is the device name listed in this FDA 510(k) record. The listed applicant is Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 2022-11-14 under 510(k) number K222490. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HBL Blade Assembly?

HBL Blade Assembly is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K222490.

When did HBL Blade Assembly receive FDA 510(k) clearance?

HBL Blade Assembly received FDA 510(k) clearance on 2022-11-14, under 510(k) number K222490.

Who is the listed applicant for HBL Blade Assembly?

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

What is the FDA product code for HBL Blade Assembly?

The FDA product code for HBL Blade Assembly is HRX.

其他以 Hand Biomechanics Lab, 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。

K252020隧道視野內視鏡軟組織釋放系統及HBL刀片組裝 K181192PIP修復

相關器械（代碼：HRX）

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。

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