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FDA 510(k)

Fine TTO™

K-Number: K250394 · 2025-10-21

Decision Date2025-10-21
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fine TTO™ is a medical device manufactured by Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2025-10-21 under approval number K250394. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fine TTO™?

Fine TTO™ is a medical device that received FDA 510(k) clearance on 2025-10-21. It is manufactured by Bodycad Laboratories, Inc.. The 510(k) number is K250394.

When was Fine TTO™ approved by the FDA?

Fine TTO™ received FDA 510(k) clearance on 2025-10-21, under approval number K250394.

What company makes Fine TTO™?

Fine TTO™ is manufactured by Bodycad Laboratories, Inc..

What is the FDA product code for Fine TTO™?

The FDA product code for Fine TTO™ is PBF.

Other Devices by Bodycad Laboratories, Inc.

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Related Devices (Code: PBF)

Official Source

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