The following data is part of a premarket notification filed by Nihon Kohden Orangemed, Inc. with the FDA for Nihon Kohden Nkv-550 Series Ventilator System.
| Device ID | K192307 |
| 510k Number | K192307 |
| Device Name: | Nihon Kohden NKV-550 Series Ventilator System |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 |
| Contact | Sheryl Higgins |
| Correspondent | Sheryl Higgins Nihon Kohden OrangeMed, Inc. 1800 E. Wilshire Avenue Santa Ana, CA 92705 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-26 |
| Decision Date | 2020-01-10 |