Annalise Enterprise
K-Number: K253818 · 2026-03-03
ApplicantHarrison-AI Medical Pty, Ltd.
Decision Date2026-03-03
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Annalise Enterprise is a medical device manufactured by Harrison-AI Medical Pty, Ltd.. It received FDA 510(k) clearance on 2026-03-03 under approval number K253818. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Annalise Enterprise?
Annalise Enterprise is a medical device that received FDA 510(k) clearance on 2026-03-03. It is manufactured by Harrison-AI Medical Pty, Ltd.. The 510(k) number is K253818.
When was Annalise Enterprise approved by the FDA?
Annalise Enterprise received FDA 510(k) clearance on 2026-03-03, under approval number K253818.
What company makes Annalise Enterprise?
Annalise Enterprise is manufactured by Harrison-AI Medical Pty, Ltd..
What is the FDA product code for Annalise Enterprise?
The FDA product code for Annalise Enterprise is QAS.
Related Devices (Code: QAS)
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.