FDA 510(k)

IQ-UIP

K 號：K242467 · 2024-12-19

決定日期2024-12-19

產品代碼QWO

諮詢委員會RA

決定相當於

器材摘要

IQ-UIP is the device name listed in this FDA 510(k) record. The listed applicant is Imbio, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242467. The device is classified under product code QWO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IQ-UIP?

IQ-UIP is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Imbio, Inc.. The 510(k) number is K242467.

When did IQ-UIP receive FDA 510(k) clearance?

IQ-UIP received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242467.

Who is the listed applicant for IQ-UIP?

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

What is the FDA product code for IQ-UIP?

The FDA product code for IQ-UIP is QWO.

其他以 Imbio, 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。

K241847Imbio PHA (4.0.0)K230112CAC軟體

相關器械（代碼：QWO）

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。

K252041Fibresolve（含PCCP）Imvaria, Inc.K241891ScreenDxImvaria, Inc.

官方來源

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