Cleared Traditional

O-TWO E700,O-TWO E600,O-TWO E500

K141595 · O-Two Medical Technologies, Inc. · Anesthesiology
Mar 2015
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K141595 is an FDA 510(k) clearance for the O-TWO E700,O-TWO E600,O-TWO E500, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by O-Two Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on March 16, 2015, 276 days after receiving the submission on June 13, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K141595 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2014
Decision Date March 16, 2015
Days to Decision 276 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

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