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FDA 510(k)

AllNEB

K-Number: K242354 · 2025-04-29

ApplicantEnchant Tek Co. , Ltd.
Decision Date2025-04-29
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AllNEB is a medical device manufactured by Enchant Tek Co. , Ltd.. It received FDA 510(k) clearance on 2025-04-29 under approval 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. It is manufactured by Enchant Tek Co. , Ltd.. The 510(k) number is K242354.

When was AllNEB approved by the FDA?

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

What company makes AllNEB?

AllNEB is manufactured by Enchant Tek Co. , Ltd..

What is the FDA product code for AllNEB?

The FDA product code for AllNEB is CAF.

Other Devices by Enchant Tek Co. , Ltd.

K233855AllPEP

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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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