510(k) K231778
- Device
- Nihon Kohden NKV-550 Series Ventilator System
- Applicant
- Nihon Kohden Orangemed, LLC
- 510(k) number
- K231778
- Product code
- CBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-01
- Date received
- 2023-06-16
- 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
- Sheryl Higgins
- Address
- 1800 E. Wilshire Ave. Santa Ana CA US 92705 92705
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
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- 3013421741
- 3029871637
- 3004748541
- 3033526676
- 9680215
- 3005783425
- 3010817335
- 3012667060
- 3009129579
- 2112667
- 1219324
- 3023272766
- 9680661
- 1314417
- 3006446479
- 9611500
- 1225492
- 3000143502
- 3038562397
- 3029845
- 3009302812
- 3016450067
- 3002797442
- 1222088
- 3014766741
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- 3007573469
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- 2020676
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- 8030673
- 3026740087
- 3025936435
- 2011171
- 3038259592
- 1924066
- 3013095415
- 3006240053
- 3018094310
- 1625392
- 1000122786
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K240807 | VM-2000 | Ventis Medical, Inc. | 2024-08-13 |
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