FDA 510(k)

Eclipse II 智能噪音消除器

K 號：K213307 · 2022-01-14

決定日期2022-01-14

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Eclipse II with Smart Noise Cancellation is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K213307. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Eclipse II with Smart Noise Cancellation?

Eclipse II with Smart Noise Cancellation is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Carestream Health, Inc.. The 510(k) number is K213307.

When did Eclipse II with Smart Noise Cancellation receive FDA 510(k) clearance?

Eclipse II with Smart Noise Cancellation received FDA 510(k) clearance on 2022-01-14, under 510(k) number K213307.

Who is the listed applicant for Eclipse II with Smart Noise Cancellation?

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

What is the FDA product code for Eclipse II with Smart Noise Cancellation?

The FDA product code for Eclipse II with Smart Noise Cancellation is MQB.

其他以 Carestream Health, Inc. 為申請人之記錄

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相關器械（代碼：MQB）

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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