FDA 510(k)

inHEART 模型

K 號：K231683 · 2024-02-29

決定日期2024-02-29

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

inHEART Models is the device name listed in this FDA 510(k) record. The listed applicant is Inheart, Sas. It received FDA 510(k) clearance on 2024-02-29 under 510(k) number K231683. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the inHEART Models?

inHEART Models is a medical device that received FDA 510(k) clearance on 2024-02-29. The listed applicant is Inheart, Sas. The 510(k) number is K231683.

When did inHEART Models receive FDA 510(k) clearance?

inHEART Models received FDA 510(k) clearance on 2024-02-29, under 510(k) number K231683.

Who is the listed applicant for inHEART Models?

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

What is the FDA product code for inHEART Models?

The FDA product code for inHEART Models is QIH.

其他以 Inheart, Sas 為申請人之記錄

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K220727inHEART 模型

相關器械（代碼：QIH）

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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