Annalise Enterprise CTB Triage-OH
K-Number: K231094 · 2023-08-15
ApplicantAnnalise-Ai Pty , Ltd.
Decision Date2023-08-15
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Annalise Enterprise CTB Triage-OH is a medical device manufactured by Annalise-Ai Pty , Ltd.. It received FDA 510(k) clearance on 2023-08-15 under approval number K231094. 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 CTB Triage-OH?
Annalise Enterprise CTB Triage-OH is a medical device that received FDA 510(k) clearance on 2023-08-15. It is manufactured by Annalise-Ai Pty , Ltd.. The 510(k) number is K231094.
When was Annalise Enterprise CTB Triage-OH approved by the FDA?
Annalise Enterprise CTB Triage-OH received FDA 510(k) clearance on 2023-08-15, under approval number K231094.
What company makes Annalise Enterprise CTB Triage-OH?
Annalise Enterprise CTB Triage-OH is manufactured by Annalise-Ai Pty , Ltd..
What is the FDA product code for Annalise Enterprise CTB Triage-OH?
The FDA product code for Annalise Enterprise CTB Triage-OH is QAS.
Other Devices by Annalise-Ai Pty , Ltd.
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.