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

Substantially Equivalent

Feops NV

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

Clearance details

Applicant: Feops NV
Product code: Code QIH
Advisory panel: Radiology
Date received: 2022-12-23
Decision date: 2023-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gent-Zwijnaarde, BE

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