Cleared Traditional

Equinox Advantage

K173205 · O-Two Medical Technologies, Inc. · Anesthesiology
Aug 2018
Decision
331d
Days
Class 2
Risk

About This 510(k) Submission

K173205 is an FDA 510(k) clearance for the Equinox Advantage, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by O-Two Medical Technologies, Inc. (Brampton, CA). The FDA issued a Cleared decision on August 29, 2018, 331 days after receiving the submission on October 2, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K173205 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2017
Decision Date August 29, 2018
Days to Decision 331 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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