Cleared Traditional

EQUINOX RELIEVE

K113687 · O-Two Medical Technologies, Inc. · Anesthesiology
Apr 2012
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K113687 is an FDA 510(k) clearance for the EQUINOX RELIEVE, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by O-Two Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on April 30, 2012, 137 days after receiving the submission on December 15, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K113687 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2011
Decision Date April 30, 2012
Days to Decision 137 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZR — Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5330

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