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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Feops NV. It received FDA 510(k) clearance on 2023-06-06 under 510(k) 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. The listed applicant is Feops NV. The 510(k) number is K223855.

When did FEops HEARTguideTM, FEops HEARTguideTM ALPACA receive FDA 510(k) clearance?

FEops HEARTguideTM, FEops HEARTguideTM ALPACA received FDA 510(k) clearance on 2023-06-06, under 510(k) number K223855.

Who is the listed applicant for FEops HEARTguideTM, FEops HEARTguideTM ALPACA?

The FDA 510(k) record lists Feops NV as the applicant. This does not by itself establish the device manufacturer.

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 records listing Feops NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250635FEops HEARTguide Simulation ApplicationK214066FEops HEARTguide

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, 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.

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