Cleared Traditional

CAREVENT HANDHELD CPAP SYSTEM

K093862 · O-Two Medical Technologies, Inc. · Anesthesiology
May 2010
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K093862 is an FDA 510(k) clearance for the CAREVENT HANDHELD CPAP SYSTEM, 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 May 6, 2010, 140 days after receiving the submission on December 17, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K093862 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2009
Decision Date May 06, 2010
Days to Decision 140 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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