FEops HEARTguideTM, FEops HEARTguideTM ALPACA— 510(k) K223855

Name: FDA 510(k) clearance K223855
Creator: U.S. Food and Drug Administration
Published: 2023-06-06

Substantially Equivalent

Feops NV

FDA 510(k) clearance K223855 for FEops HEARTguideTM, FEops HEARTguideTM ALPACA, Substantially Equivalent on 2023-06-06. Applicant: Feops NV. Device class: 2.

Clearance details

Applicant: Feops NV
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-12-23
Decision date: 2023-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gent-Zwijnaarde, BE

Download summary PDF View on FDA.gov ↗

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More clearances from Feops NV

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Data sourced from openFDA. This site is unofficial and independent of the FDA.