Cleared Traditional

Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask

K241943 · Sleepnet Corporation · Anesthesiology
Aug 2024
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K241943 is an FDA 510(k) clearance for the Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Sleepnet Corporation (Hampton, US). The FDA issued a Cleared decision on August 28, 2024, 57 days after receiving the submission on July 2, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K241943 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2024
Decision Date August 28, 2024
Days to Decision 57 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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