Triathlon Pro— 510(k) K243131
Substantially EquivalentSigma Biomedical
FDA 510(k) clearance K243131 for Triathlon Pro, Substantially Equivalent on 2025-11-07. Applicant: Sigma Biomedical. Device class: 2.
Clearance details
- Applicant
- Sigma Biomedical
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- 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.