The following data is part of a premarket notification filed by Nihon Kohden Orangemed, Inc. with the FDA for Nihon Kohden Nkv-330 Ventilator System.
| Device ID | K213521 |
| 510k Number | K213521 |
| Device Name: | Nihon Kohden NKV-330 Ventilator System |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 |
| Contact | Jacqueline Villanueva |
| Correspondent | Jacqueline Villanueva Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-03 |
| Decision Date | 2022-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843685100043 | K213521 | 000 |
| 10843685100170 | K213521 | 000 |
| 00843685100135 | K213521 | 000 |
| 20843685100078 | K213521 | 000 |
| 10843685100064 | K213521 | 000 |
| 10843685100057 | K213521 | 000 |