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FDA 510(k)

AllNEB

K-Number: K242354 · 2025-04-29

Decision Date2025-04-29
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AllNEB is the device name listed in this FDA 510(k) record. The listed applicant is Enchant Tek Co. , Ltd.. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K242354. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AllNEB?

AllNEB is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Enchant Tek Co. , Ltd.. The 510(k) number is K242354.

When did AllNEB receive FDA 510(k) clearance?

AllNEB received FDA 510(k) clearance on 2025-04-29, under 510(k) number K242354.

Who is the listed applicant for AllNEB?

The FDA 510(k) record lists Enchant Tek Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllNEB?

The FDA product code for AllNEB is CAF.

Other records listing Enchant Tek Co. , Ltd. 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.

Related Devices (Code: CAF)

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.

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.