K-number	K243131
Device name	Triathlon Pro
Applicant	Sigma Biomedical
Product code	NUH
Device class	Class II
Decision date	Nov 7, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Triathlon Pro

Everything you need for a 510(k) submission. Nothing you don't.