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FDA 510(k)

CaloPix

K-Number: K250414 · 2025-05-14

ApplicantTribun Health
Decision Date2025-05-14
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

CaloPix is a medical device manufactured by Tribun Health. It received FDA 510(k) clearance on 2025-05-14 under approval number K250414. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CaloPix?

CaloPix is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Tribun Health. The 510(k) number is K250414.

When was CaloPix approved by the FDA?

CaloPix received FDA 510(k) clearance on 2025-05-14, under approval number K250414.

What company makes CaloPix?

CaloPix is manufactured by Tribun Health.

What is the FDA product code for CaloPix?

The FDA product code for CaloPix is QKQ.

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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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