510(k) K252173
- Device
- 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
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- 510(k) number
- K252173
- Product code
- CBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-10
- Date received
- 2025-07-11
- 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
Related Records
Applicant Contact
- Contact
- Reena Daken
- Address
- 15 Maurice Paykel Pl., E. Tamaki Auckland NZ 2013 2013
FDA Registration Numbers
- 2021710
- 9615827
- 3004604967
- 2221819
- 9710602
- 8020893
- 1722070
- 3009609218
- 3029227324
- 2134715
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- 3010291427
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- 3029922922
- 8010042
- 3018783526
- 2518436
- 3031369651
- 3013154126
- 2085602
- 3021947238
- 3012307300
- 9617566
- 3007344957
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- 8010939
- 3010017366
- 3003908598
- 3006135941
- 1000604079
- 3010952312
- 3011120183
- 3009107628
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- 3014631252
- 3030733800
- 3004050971
- 3010157426
- 8021084
- 3011190789
- 3020283264
- 1066270
- 3016618143
- 3011213495
- 3006807694
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- 9611295
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- 3010317211
- 3011205710
- 2024500
- 9611451
- 3007238566
- 3008102042
- 3000126629
- 3030446844
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- 1218058
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- 2011171
- 3038259592
- 1924066
- 3013095415
- 3006240053
- 3018094310
- 1625392
- 1000122786
Source Documents
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| 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 |