The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u Mr Ventilator System 4.1.
| Device ID | K201874 |
| 510k Number | K201874 |
| Device Name: | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Maquet Critical Care AB Rontgenvagen 2 Solna, SE 17154 |
| Contact | David Ardanius |
| Correspondent | Mark N Smith Getinge 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 | 2020-07-07 |
| Decision Date | 2021-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07325710012185 | K201874 | 000 |
| 07325710010518 | K201874 | 000 |
| 07325710012673 | K201874 | 000 |