Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask— 510(k) K190254
Substantially EquivalentSleepnet Corporation
FDA 510(k) clearance K190254 for Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask, Substantially Equivalent on 2019-07-05. Applicant: Sleepnet Corporation. Device class: 2.
Clearance details
- Applicant
- Sleepnet Corporation
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hampton, NH, US
Recent devices under product code BZD
view allMore clearances from Sleepnet Corporation
view all- K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
- K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
- K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
- K241661 — Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
- K241520 — Mojo 2 Full Face Non-Vented Mask +3 more
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
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 K190254
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190254.
Data sourced from openFDA. This site is unofficial and independent of the FDA.