HPACS
K-Number: K250039 · 2025-10-03
ApplicantHealthhub
Decision Date2025-10-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HPACS is the device name listed in this FDA 510(k) record. The listed applicant is Healthhub. It received FDA 510(k) clearance on 2025-10-03 under 510(k) 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. The listed applicant is Healthhub. The 510(k) number is K250039.
When did HPACS receive FDA 510(k) clearance?
HPACS received FDA 510(k) clearance on 2025-10-03, under 510(k) number K250039.
Who is the listed applicant for HPACS?
The FDA 510(k) record lists Healthhub as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HPACS?
The FDA product code for HPACS is LLZ.
Related Devices (Code: LLZ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
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