FEops HEARTguide
K-Number: K214066 · 2022-02-25
ApplicantFeops NV
Decision Date2022-02-25
Product CodeQQI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FEops HEARTguide is a medical device manufactured by Feops NV. It received FDA 510(k) clearance on 2022-02-25 under approval number K214066. The device is classified under product code QQI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FEops HEARTguide?
FEops HEARTguide is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by Feops NV. The 510(k) number is K214066.
When was FEops HEARTguide approved by the FDA?
FEops HEARTguide received FDA 510(k) clearance on 2022-02-25, under approval number K214066.
What company makes FEops HEARTguide?
FEops HEARTguide is manufactured by Feops NV.
What is the FDA product code for FEops HEARTguide?
The FDA product code for FEops HEARTguide is QQI.
Other Devices by Feops NV
Related Devices (Code: QQI)
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.