The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Servo-i Ventilator System, Models 64, 87 And 800.
| Device ID | K063404 |
| 510k Number | K063404 |
| Device Name: | SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | MAQUET CRITICAL CARE AB 1140 ROUTE 22 EAST SUITE 202 Bridgewater, NJ 08807 |
| Contact | Jamie Yieh |
| Correspondent | Jamie Yieh MAQUET CRITICAL CARE AB 1140 ROUTE 22 EAST SUITE 202 Bridgewater, NJ 08807 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2007-02-15 |
| Summary: | summary |