FDA 510(k)

APPRAISE-HRI

K-Number: K233249 · 2024-04-05

ApplicantThe Surgeon General, Department of the Army (TSG-DA)

Decision Date2024-04-05

Product CodeSAR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing The Surgeon General, Department of the Army (TSG-DA) as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.