Annalise Enterprise CTB Triage Trauma
K-Number: K223240 · 2023-04-03
ApplicantAnnalise-Ai Pty , Ltd.
Decision Date2023-04-03
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Annalise Enterprise CTB Triage Trauma is a medical device manufactured by Annalise-Ai Pty , Ltd.. It received FDA 510(k) clearance on 2023-04-03 under approval number K223240. 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 Trauma?
Annalise Enterprise CTB Triage Trauma is a medical device that received FDA 510(k) clearance on 2023-04-03. It is manufactured by Annalise-Ai Pty , Ltd.. The 510(k) number is K223240.
When was Annalise Enterprise CTB Triage Trauma approved by the FDA?
Annalise Enterprise CTB Triage Trauma received FDA 510(k) clearance on 2023-04-03, under approval number K223240.
What company makes Annalise Enterprise CTB Triage Trauma?
Annalise Enterprise CTB Triage Trauma is manufactured by Annalise-Ai Pty , Ltd..
What is the FDA product code for Annalise Enterprise CTB Triage Trauma?
The FDA product code for Annalise Enterprise CTB Triage Trauma 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.