Caas Qardia
K-Number: K212376 · 2022-05-16
ApplicantPie Medical Imaging BV
Decision Date2022-05-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Caas Qardia is a medical device manufactured by Pie Medical Imaging BV. It received FDA 510(k) clearance on 2022-05-16 under approval number K212376. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Caas Qardia?
Caas Qardia is a medical device that received FDA 510(k) clearance on 2022-05-16. It is manufactured by Pie Medical Imaging BV. The 510(k) number is K212376.
When was Caas Qardia approved by the FDA?
Caas Qardia received FDA 510(k) clearance on 2022-05-16, under approval number K212376.
What company makes Caas Qardia?
Caas Qardia is manufactured by Pie Medical Imaging BV.
What is the FDA product code for Caas Qardia?
The FDA product code for Caas Qardia is LLZ.
Other Devices by Pie Medical Imaging BV
Related Devices (Code: LLZ)
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.