AllPEP— 510(k) K233855

Substantially Equivalent

Enchant Tek Co. , Ltd.

FDA 510(k) clearance K233855 for AllPEP, Substantially Equivalent on 2024-02-02. Applicant: Enchant Tek Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Enchant Tek Co. , Ltd.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2023-12-05
Decision date: 2024-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yilan County, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.