Cleared Traditional

MaxO2ME

K153659 · Maxtec, LLC · Anesthesiology
Jun 2016
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K153659 is an FDA 510(k) clearance for the MaxO2ME, 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 June 10, 2016, 172 days after receiving the submission on December 21, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number K153659 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2015
Decision Date June 10, 2016
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCL — Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1720