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FDA 510(k)

Triathlon Pro

K-Number: K243131 · 2025-11-07

ApplicantSigma Biomedical
Decision Date2025-11-07
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Triathlon Pro is a medical device manufactured by Sigma Biomedical. It received FDA 510(k) clearance on 2025-11-07 under approval number K243131. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon Pro?

Triathlon Pro is a medical device that received FDA 510(k) clearance on 2025-11-07. It is manufactured by Sigma Biomedical. The 510(k) number is K243131.

When was Triathlon Pro approved by the FDA?

Triathlon Pro received FDA 510(k) clearance on 2025-11-07, under approval number K243131.

What company makes Triathlon Pro?

Triathlon Pro is manufactured by Sigma Biomedical.

What is the FDA product code for Triathlon Pro?

The FDA product code for Triathlon Pro is NUH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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