FDA 510(k)

再製Eagle Eye Platinum RX數位內視鏡冠狀動脈內脈管

K 號：K210655 · 2022-05-25

決定日期2022-05-25

產品代碼OWQ

諮詢委員會履歷

決定相當於

器材摘要

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K210655. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Innovative Health, LLC. The 510(k) number is K210655.

When did Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter receive FDA 510(k) clearance?

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter received FDA 510(k) clearance on 2022-05-25, under 510(k) number K210655.

Who is the listed applicant for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

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

What is the FDA product code for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter?

The FDA product code for Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is OWQ.

其他以 Innovative Health, LLC 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。

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相關器械（代碼：OWQ）

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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