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FDA 510(k)

Encora X1

K 號：K251517 · 2026-02-05

申請人Encora, Inc.
決定日期2026-02-05
產品代碼QBC
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

Encora X1 is the device name listed in this FDA 510(k) record. The listed applicant is Encora, Inc.. It received FDA 510(k) clearance on 2026-02-05 under 510(k) number K251517. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Encora X1?

Encora X1 is a medical device that received FDA 510(k) clearance on 2026-02-05. The listed applicant is Encora, Inc.. The 510(k) number is K251517.

When did Encora X1 receive FDA 510(k) clearance?

Encora X1 received FDA 510(k) clearance on 2026-02-05, under 510(k) number K251517.

Who is the listed applicant for Encora X1?

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

What is the FDA product code for Encora X1?

The FDA product code for Encora X1 is QBC.

相關臨床試驗

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相關器械（代碼：QBC）

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官方來源

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