Annalise Enterprise CTB Triage Trauma
K-Number: K231384 · 2023-09-22
ApplicantAnnalise-Ai Pty , Ltd.
Decision Date2023-09-22
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 2023-09-22 under approval number K231384. 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 2023-09-22. It is manufactured by Annalise-Ai Pty , Ltd.. The 510(k) number is K231384.
When was Annalise Enterprise CTB Triage Trauma approved by the FDA?
Annalise Enterprise CTB Triage Trauma received FDA 510(k) clearance on 2023-09-22, under approval number K231384.
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.