FDA 510(k)

EzSensor HD，EzSensor UHD

K 號：K252570 · 2025-11-10

決定日期2025-11-10

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

EzSensor HD, EzSensor UHD is the device name listed in this FDA 510(k) record. The listed applicant is Qpix Solutions, Inc.. It received FDA 510(k) clearance on 2025-11-10 under 510(k) number K252570. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EzSensor HD, EzSensor UHD?

EzSensor HD, EzSensor UHD is a medical device that received FDA 510(k) clearance on 2025-11-10. The listed applicant is Qpix Solutions, Inc.. The 510(k) number is K252570.

When did EzSensor HD, EzSensor UHD receive FDA 510(k) clearance?

EzSensor HD, EzSensor UHD received FDA 510(k) clearance on 2025-11-10, under 510(k) number K252570.

Who is the listed applicant for EzSensor HD, EzSensor UHD?

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

What is the FDA product code for EzSensor HD, EzSensor UHD?

The FDA product code for EzSensor HD, EzSensor UHD is MUH.

其他以 Qpix Solutions, 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。

K242778X感測器（型號：IOS-A15IF，HDI-15DGF）K232255EZSensor XHD

相關器械（代碼：MUH）

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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官方來源

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