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FDA 510(k)

OnX Tough

K-Number: K230445 · 2023-07-14

ApplicantSprintray, Inc.
Decision Date2023-07-14
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OnX Tough is a medical device manufactured by Sprintray, Inc.. It received FDA 510(k) clearance on 2023-07-14 under approval number K230445. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OnX Tough?

OnX Tough is a medical device that received FDA 510(k) clearance on 2023-07-14. It is manufactured by Sprintray, Inc.. The 510(k) number is K230445.

When was OnX Tough approved by the FDA?

OnX Tough received FDA 510(k) clearance on 2023-07-14, under approval number K230445.

What company makes OnX Tough?

OnX Tough is manufactured by Sprintray, Inc..

What is the FDA product code for OnX Tough?

The FDA product code for OnX Tough is EBI.

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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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