FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
K Number: K190254
·
Decision Jul 5, 2019
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
23
Review Days
148
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Basic Information
- Device Name
- Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
- K Number
- K190254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sleepnet Corporation
- Date Received
- February 7, 2019
- Decision Date
- July 5, 2019
- Product Code
- BZD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by Sleepnet Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Jan 15, 2026 | Substantially Equivalent |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | Oct 18, 2024 | Substantially Equivalent |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | Aug 28, 2024 | Substantially Equivalent |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | Jul 10, 2024 | Substantially Equivalent |
| K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | Jun 27, 2024 | Substantially Equivalent |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Jun 15, 2024 | Substantially Equivalent |
| K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | Jan 10, 2022 | Substantially Equivalent |
| K203601 | Innova Nasal Non-Vented Mask | Apr 30, 2021 | Substantially Equivalent |
| K190533 | 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 | Jul 26, 2019 | Substantially Equivalent |
| K121321 | HARD SHELL VENTED NASAL MASK | Nov 30, 2012 | Substantially Equivalent |