Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented— 510(k) K190533

Substantially Equivalent

Sleepnet Corporation

FDA 510(k) clearance K190533 for Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented, Substantially Equivalent on 2019-07-26. Applicant: Sleepnet Corporation.

Clearance details

Applicant: Sleepnet Corporation
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 2019-03-04
Decision date: 2019-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.