Cleared Traditional

Maxtec MaxO2 ME+p

K221734 · Maxtec, LLC · Anesthesiology

Apr 2023

Decision

290d

Days

Class 2

Risk

About This 510(k) Submission

K221734 is an FDA 510(k) clearance for the Maxtec MaxO2 ME+p, a Analyzer, Gas, Oxygen, Gaseous-phase (Class II — Special Controls, product code CCL), submitted by Maxtec, LLC (Salt Lake City, US). The FDA issued a Cleared decision on April 1, 2023, 290 days after receiving the submission on June 15, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number	K221734 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2022
Decision Date	April 01, 2023
Days to Decision	290 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF