FDA 510(k)

EQ-PEX

K 號：K210789 · 2021-10-20

決定日期2021-10-20

產品代碼LQY

決定相當於

器材摘要

EQ-PEX is the device name listed in this FDA 510(k) record. The listed applicant is Meta Systems Co., Ltd.. It received FDA 510(k) clearance on 2021-10-20 under 510(k) number K210789. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

常見問題

What is the EQ-PEX?

EQ-PEX is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Meta Systems Co., Ltd.. The 510(k) number is K210789.

When did EQ-PEX receive FDA 510(k) clearance?

EQ-PEX received FDA 510(k) clearance on 2021-10-20, under 510(k) number K210789.

Who is the listed applicant for EQ-PEX?

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

What is the FDA product code for EQ-PEX?

The FDA product code for EQ-PEX is LQY.

其他以 Meta Systems Co., Ltd. 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。

K253461德米專業版 K210475EQ-M K153285EMS-200

相關器械（代碼：LQY）

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。

K252224Apex 定位器 (FindPex)Changzhou Sifary Medical Technology Co., Ltd.K242383Apex 定位器Shenzhen Rogin Medical Co., Ltd.K242765電子尖峰定位器（Alpha Apex I）SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K231990Apex 定位器Cefla S.C.K232717Apex 定位器 (AL-Pex), Apex 定位器 (AL-Pex+)Changzhou Haili Medical Co., Ltd.K212178根端定位器Foshan Coxo Medical Instrument Co., Ltd.

官方來源

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