The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Servo-u Ventilator System Version 2.1; Servo-n Ventilator System Version 2.1.
| Device ID | K180098 |
| 510k Number | K180098 |
| Device Name: | SERVO-U Ventilator System Version 2.1; SERVO-n Ventilator System Version 2.1 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Maquet Critical Care AB Rontgenvagen 2 Solna, SE 17154 |
| Contact | Jerker Aberg |
| Correspondent | Mark Dinger Maquet Medical System USA 45 Barbour Pond Drive Wayne, NJ 07470 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2019-03-19 |