Cleared Traditional

AllPEP

K233855 · Enchant Tek Co. , Ltd. · Anesthesiology
Feb 2024
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K233855 is an FDA 510(k) clearance for the AllPEP, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Enchant Tek Co. , Ltd. (Yilan County, TW). The FDA issued a Cleared decision on February 2, 2024, 59 days after receiving the submission on December 5, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K233855 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2023
Decision Date February 02, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWF — Spirometer, Therapeutic (incentive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5690