Cleared Abbreviated

ULTRAMAXO2 OXYGEN ANALYER

K112402 · Maxtec, LLC · Anesthesiology
Dec 2011
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K112402 is an FDA 510(k) clearance for the ULTRAMAXO2 OXYGEN ANALYER, 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 December 14, 2011, 114 days after receiving the submission on August 22, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number K112402 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2011
Decision Date December 14, 2011
Days to Decision 114 days
Submission Type Abbreviated
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