FDA 510(k)

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K 號：K203719 · 2021-01-19

決定日期2021-01-19

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

IntraSight Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2021-01-19 under 510(k) number K203719. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IntraSight Mobile?

IntraSight Mobile is a medical device that received FDA 510(k) clearance on 2021-01-19. The listed applicant is Volcano Corporation. The 510(k) number is K203719.

When did IntraSight Mobile receive FDA 510(k) clearance?

IntraSight Mobile received FDA 510(k) clearance on 2021-01-19, under 510(k) number K203719.

Who is the listed applicant for IntraSight Mobile?

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

What is the FDA product code for IntraSight Mobile?

The FDA product code for IntraSight Mobile is IYO.

其他以 Volcano Corporation 為申請人之記錄

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相關器械（代碼：IYO）

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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