FDA 510(k)

APPRAISE-HRI

K 號：K233249 · 2024-04-05

申請人The Surgeon General, Department of the Army (TSG-DA)

決定日期2024-04-05

產品代碼SAR

諮詢委員會履歷

決定相當於

器材摘要

APPRAISE-HRI is the device name listed in this FDA 510(k) record. The listed applicant is The Surgeon General, Department of the Army (TSG-DA). It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K233249. The device is classified under product code SAR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the APPRAISE-HRI?

APPRAISE-HRI is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is The Surgeon General, Department of the Army (TSG-DA). The 510(k) number is K233249.

When did APPRAISE-HRI receive FDA 510(k) clearance?

APPRAISE-HRI received FDA 510(k) clearance on 2024-04-05, under 510(k) number K233249.

Who is the listed applicant for APPRAISE-HRI?

The FDA 510(k) record lists The Surgeon General, Department of the Army (TSG-DA) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APPRAISE-HRI?

The FDA product code for APPRAISE-HRI is SAR.

其他以 The Surgeon General, Department of the Army (TSG-DA) 為申請人之記錄

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