HeartFocus (V.1.1.1)— 510(k) K242807

Substantially Equivalent

Deski

FDA 510(k) clearance K242807 for HeartFocus (V.1.1.1), Substantially Equivalent on 2025-04-04. Applicant: Deski.

Clearance details

Applicant: Deski
Product code: Code QJU
Advisory panel: Radiology
Date received: 2024-09-17
Decision date: 2025-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bordeaux, FR

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