FDA 510(k)

Klaxon (Twist); Klaxon (Twist R)

K-Number: K240267 · 2025-01-10

Decision Date2025-01-10

Product CodeITI

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Klaxon (Twist); Klaxon (Twist R) is a medical device manufactured by Klaxon Mobility GmbH. It received FDA 510(k) clearance on 2025-01-10 under approval number K240267. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Klaxon (Twist); Klaxon (Twist R)?

Klaxon (Twist); Klaxon (Twist R) is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Klaxon Mobility GmbH. The 510(k) number is K240267.

When was Klaxon (Twist); Klaxon (Twist R) approved by the FDA?

Klaxon (Twist); Klaxon (Twist R) received FDA 510(k) clearance on 2025-01-10, under approval number K240267.

What company makes Klaxon (Twist); Klaxon (Twist R)?

Klaxon (Twist); Klaxon (Twist R) is manufactured by Klaxon Mobility GmbH.

What is the FDA product code for Klaxon (Twist); Klaxon (Twist R)?

The FDA product code for Klaxon (Twist); Klaxon (Twist R) is ITI.

Other Devices by Klaxon Mobility GmbH

K222502KLICK (VARIANTS: POWER, RACE, MONSTER)

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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.