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FDA 510(k)

HPACS

K-Number: K250039 · 2025-10-03

ApplicantHealthhub
Decision Date2025-10-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HPACS is a medical device manufactured by Healthhub. It received FDA 510(k) clearance on 2025-10-03 under approval number K250039. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HPACS?

HPACS is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by Healthhub. The 510(k) number is K250039.

When was HPACS approved by the FDA?

HPACS received FDA 510(k) clearance on 2025-10-03, under approval number K250039.

What company makes HPACS?

HPACS is manufactured by Healthhub.

What is the FDA product code for HPACS?

The FDA product code for HPACS is LLZ.

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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.

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