Cleared Traditional

O_TWO CPAP SYSTEM

K112546 · O-Two Medical Technologies, Inc. · Anesthesiology
Dec 2011
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K112546 is an FDA 510(k) clearance for the O_TWO CPAP SYSTEM, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by O-Two Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on December 27, 2011, 117 days after receiving the submission on September 1, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number K112546 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2011
Decision Date December 27, 2011
Days to Decision 117 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYE — Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5965

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