eMurmur Heart AI— 510(k) K252284

Substantially Equivalent

Csd Labs

FDA 510(k) clearance K252284 for eMurmur Heart AI, Substantially Equivalent on 2025-12-19. Applicant: Csd Labs.

Clearance details

Applicant: Csd Labs
Product code: Code DQD
Advisory panel: Cardiovascular
Date received: 2025-07-22
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Graz, AT

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