510(k) K093094
- Device
- VELA VENTILATOR
- Applicant
- CARDINAL HEALTH 207, INC.
- 510(k) number
- K093094
- Product code
- CBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-11
- Date received
- 2009-10-01
- 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
- No
Applicant Contact#
- Contact
- FAROKH ETEMADIEH
- Address
- 22745 Savi Ranch Pkwy. Yorba Linda CA US 92887 92887
FDA Registration Numbers#
- 3002797442
- 3007344957
- 1314417
- 3000143502
- 3009156722
- 2024500
- 3003908598
- 3033571078
- 2112667
- 3012667060
- 3029906224
- 3013154126
- 3031369651
- 3000126629
- 3030733800
- 2221819
- 3005783425
- 3013095415
- 1220908
- 3014766741
- 3011120183
- 3020283264
- 3016618143
- 2134715
- 3038562397
- 3009490946
- 3012307300
- 3018094310
- 3009107628
- 1066270
- 1625392
- 3006807694
- 9617566
- 3006240053
- 3008496839
- 1000122786
- 2085602
- 1316463
- 3038259592
- 8010042
- 3009129579
- 3004604967
- 3008264065
- 3007549157
- 3007238566
- 8030941
- 9611500
- 3011190789
- 3025936435
- 3029227324
- 3029845
- 2518422
- 3011205710
- 3004428458
- 3032026475
- 2518436
- 3009077524
- 8010939
- 3021607937
- 3030446844
- 9681384
- 3006783791
- 1218704
- 3003135857
- 2020676
- 3010291427
- 3009609218
- 3006135941
- 3033526676
- 3009302812
- 3003477135
- 2112020
- 3010017366
- 3021244152
- 3010882708
- 3014631252
- 3006446479
- 1225492
- 3010088563
- 3029871637
Source Documents#
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 |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | Sleepnet Corporation | 2024-08-28 |
| 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 |
Legacy Summary#
summary
FDA Review#
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