Annalise Enterprise CXR Triage Pneumothorax
K-Number: K213941 · 2022-02-24
ApplicantAnnalise-Ai
Decision Date2022-02-24
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Annalise Enterprise CXR Triage Pneumothorax is a medical device manufactured by Annalise-Ai. It received FDA 510(k) clearance on 2022-02-24 under approval number K213941. 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 CXR Triage Pneumothorax?
Annalise Enterprise CXR Triage Pneumothorax is a medical device that received FDA 510(k) clearance on 2022-02-24. It is manufactured by Annalise-Ai. The 510(k) number is K213941.
When was Annalise Enterprise CXR Triage Pneumothorax approved by the FDA?
Annalise Enterprise CXR Triage Pneumothorax received FDA 510(k) clearance on 2022-02-24, under approval number K213941.
What company makes Annalise Enterprise CXR Triage Pneumothorax?
Annalise Enterprise CXR Triage Pneumothorax is manufactured by Annalise-Ai.
What is the FDA product code for Annalise Enterprise CXR Triage Pneumothorax?
The FDA product code for Annalise Enterprise CXR Triage Pneumothorax 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.