DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Sleepnet Corporation
Product code
Code CBK
Device class
Class 2
Regulation
21 CFR 868.5895
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hampton, NH, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CBK

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More clearances from Sleepnet Corporation

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K190533

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190533.

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