FDA 510(k)

AllPEP

K-Number: K233855 · 2024-02-02

Decision Date2024-02-02

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AllPEP 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 2024-02-02 under 510(k) number K233855. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AllPEP?

AllPEP is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Enchant Tek Co. , Ltd.. The 510(k) number is K233855.

When did AllPEP receive FDA 510(k) clearance?

AllPEP received FDA 510(k) clearance on 2024-02-02, under 510(k) number K233855.

Who is the listed applicant for AllPEP?

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 AllPEP?

The FDA product code for AllPEP is BWF.

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.

K242354AllNEB

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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.