510(k) K241943
- Device
- Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
- Applicant
- Sleepnet Corporation
- 510(k) number
- K241943
- Product code
- CBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-28
- Date received
- 2024-07-02
- Regulation
- 868.5895
- Classification name
- Ventilator, Continuous, Facility Use
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jennifer Kennedy
- Address
- 5 Merrill Industrial Dr. Hampton NH US 03842 03842
FDA Registration Numbers
- 2021710
- 9615827
- 3004604967
- 2221819
- 9710602
- 8020893
- 1722070
- 3009609218
- 3029227324
- 2134715
- 3004428458
- 3010291427
- 3009156722
- 3006087789
- 3009077524
- 3003135857
- 3003862188
- 3029922922
- 8010042
- 3018783526
- 2518436
- 3031369651
- 3013154126
- 2085602
- 3021947238
- 3012307300
- 9617566
- 3007344957
- 3033571078
- 8010939
- 3010017366
- 3003908598
- 3006135941
- 1000604079
- 3010952312
- 3011120183
- 3009107628
- 3021607937
- 3014631252
- 3030733800
- 3004050971
- 3010157426
- 8021084
- 3011190789
- 3020283264
- 1066270
- 3016618143
- 3011213495
- 3006807694
- 3016723884
- 3007603826
- 2518422
- 3007549157
- 8030941
- 3008363989
- 3021244152
- 3003697063
- 9611295
- 9681384
- 3030149975
- 3003477135
- 3010317211
- 3011205710
- 2024500
- 9611451
- 3007238566
- 3008102042
- 3000126629
- 3030446844
- 3017520736
- 1218058
- 3009490946
- 3001421318
- 1218704
- 3008867836
- 3010834934
- 3029906224
- 3008264065
- 3013421741
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code CBK
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | 2026-05-07 |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | 2026-04-14 |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026-03-12 |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025-12-19 |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Fisher & Paykel Healthcare, Ltd. | 2025-09-10 |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-28 |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | 2025-05-08 |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024-12-30 |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024-12-13 |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | 2024-12-02 |
| K241135 | RESPOND(R) Ventilator | Corvent Medical, Inc. | 2024-11-13 |
| K232836 | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | 2024-08-14 |
| K240807 | VM-2000 | Ventis Medical, Inc. | 2024-08-13 |
| 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 | Sleepnet Corporation | 2024-06-27 |
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | 2024-03-01 |