FDA 510(k)

HepaFatSmart (V2.0.0)

K 號：K231459 · 2023-06-20

申請人Resonance Health Analysis Services Pty, Ltd.

決定日期2023-06-20

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

HepaFatSmart (V2.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K231459. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HepaFatSmart (V2.0.0)?

HepaFatSmart (V2.0.0) is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K231459.

When did HepaFatSmart (V2.0.0) receive FDA 510(k) clearance?

HepaFatSmart (V2.0.0) received FDA 510(k) clearance on 2023-06-20, under 510(k) number K231459.

Who is the listed applicant for HepaFatSmart (V2.0.0)?

The FDA 510(k) record lists Resonance Health Analysis Services Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HepaFatSmart (V2.0.0)?

The FDA product code for HepaFatSmart (V2.0.0) is LNH.

其他以 Resonance Health Analysis Services Pty, Ltd. 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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