Annalise Enterprise
K-Number: K250831 · 2025-04-23
ApplicantAnnalise-Ai
Decision Date2025-04-23
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Annalise Enterprise is a medical device manufactured by Annalise-Ai. It received FDA 510(k) clearance on 2025-04-23 under approval number K250831. The device is classified under product code QFM. 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 2025-04-23. It is manufactured by Annalise-Ai. The 510(k) number is K250831.
When was Annalise Enterprise approved by the FDA?
Annalise Enterprise received FDA 510(k) clearance on 2025-04-23, under approval number K250831.
What company makes Annalise Enterprise?
Annalise Enterprise is manufactured by Annalise-Ai.
What is the FDA product code for Annalise Enterprise?
The FDA product code for Annalise Enterprise is QFM.
Other Devices by Annalise-Ai
Related Devices (Code: QFM)
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.