FEops HEARTguideTM, FEops HEARTguideTM ALPACA
K-Number: K223855 · 2023-06-06
ApplicantFeops NV
Decision Date2023-06-06
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FEops HEARTguideTM, FEops HEARTguideTM ALPACA is a medical device manufactured by Feops NV. It received FDA 510(k) clearance on 2023-06-06 under approval number K223855. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FEops HEARTguideTM, FEops HEARTguideTM ALPACA?
FEops HEARTguideTM, FEops HEARTguideTM ALPACA is a medical device that received FDA 510(k) clearance on 2023-06-06. It is manufactured by Feops NV. The 510(k) number is K223855.
When was FEops HEARTguideTM, FEops HEARTguideTM ALPACA approved by the FDA?
FEops HEARTguideTM, FEops HEARTguideTM ALPACA received FDA 510(k) clearance on 2023-06-06, under approval number K223855.
What company makes FEops HEARTguideTM, FEops HEARTguideTM ALPACA?
FEops HEARTguideTM, FEops HEARTguideTM ALPACA is manufactured by Feops NV.
What is the FDA product code for FEops HEARTguideTM, FEops HEARTguideTM ALPACA?
The FDA product code for FEops HEARTguideTM, FEops HEARTguideTM ALPACA is QIH.
Other Devices by Feops NV
Related Devices (Code: QIH)
K191647QLAB Advanced Quantification SoftwarePhilips Health Care
K191171EchoGo CoreUltromics, Ltd.
K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.
K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.
K202546LVivo SeamlessDia Imaging Analysis, Ltd.
K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.
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.