K243131

Substantially Equivalent

Triathlon Pro

Applicant: Sigma Biomedical
Product code: NUH
Advisory panel: Neurology
Date received: 2024-09-30
Decision date: 2025-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunrise, FL, US

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