The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Servo-i Ventilator System.
| Device ID | K123149 |
| 510k Number | K123149 |
| Device Name: | SERVO-I VENTILATOR SYSTEM |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | MAQUET CRITICAL CARE AB 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Whitney Torning |
| Correspondent | Whitney Torning MAQUET CRITICAL CARE AB 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-05 |
| Decision Date | 2014-06-20 |
| Summary: | summary |