Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

APPRAISE-HRI

K-Number: K233249 · 2024-04-05

Decision Date2024-04-05
Product CodeSAR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APPRAISE-HRI is a medical device manufactured by The Surgeon General, Department of the Army (TSG-DA). It received FDA 510(k) clearance on 2024-04-05 under approval 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. It is manufactured by The Surgeon General, Department of the Army (TSG-DA). The 510(k) number is K233249.

When was APPRAISE-HRI approved by the FDA?

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

What company makes APPRAISE-HRI?

APPRAISE-HRI is manufactured by The Surgeon General, Department of the Army (TSG-DA).

What is the FDA product code for APPRAISE-HRI?

The FDA product code for APPRAISE-HRI is SAR.

Official Source

View on FDA Database →

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