Cleared Traditional

EOlife?

K221841 · Archeon · Anesthesiology
Mar 2023
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K221841 is an FDA 510(k) clearance for the EOlife?, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Archeon (Besan?on, FR). The FDA issued a Cleared decision on March 18, 2023, 267 days after receiving the submission on June 24, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K221841 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2022
Decision Date March 18, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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