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FDA 510(k)

KLAXON (TWIST); KLAXON (TWIST R)

K-Number: K250748 · 2025-04-11

ApplicantKlaxon-Mobility GmbH
Decision Date2025-04-11
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KLAXON (TWIST); KLAXON (TWIST R) is the device name listed in this FDA 510(k) record. The listed applicant is Klaxon-Mobility GmbH. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K250748. 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 2025-04-11. The listed applicant is Klaxon-Mobility GmbH. The 510(k) number is K250748.

When did KLAXON (TWIST); KLAXON (TWIST R) receive FDA 510(k) clearance?

KLAXON (TWIST); KLAXON (TWIST R) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250748.

Who is the listed applicant for KLAXON (TWIST); KLAXON (TWIST R)?

The FDA 510(k) record lists Klaxon-Mobility GmbH as the applicant. This does not by itself establish the device manufacturer.

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 records listing Klaxon-Mobility GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ITI)

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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.

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