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FDA 510(k)

3Delta UNlimited

K-Number: K243720 · 2024-12-18

ApplicantDeltamed GmbH
Decision Date2024-12-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3Delta UNlimited is the device name listed in this FDA 510(k) record. The listed applicant is Deltamed GmbH. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K243720. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3Delta UNlimited?

3Delta UNlimited is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Deltamed GmbH. The 510(k) number is K243720.

When did 3Delta UNlimited receive FDA 510(k) clearance?

3Delta UNlimited received FDA 510(k) clearance on 2024-12-18, under 510(k) number K243720.

Who is the listed applicant for 3Delta UNlimited?

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

What is the FDA product code for 3Delta UNlimited?

The FDA product code for 3Delta UNlimited is EBF.

Other records listing Deltamed 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: EBF)

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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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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