Cleared Traditional

SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED

K063806 · Sleepnet Corporation · Anesthesiology
May 2007
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K063806 is an FDA 510(k) clearance for the SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on May 17, 2007, 146 days after receiving the submission on December 22, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K063806 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2006
Decision Date May 17, 2007
Days to Decision 146 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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