The following data is part of a premarket notification filed by Maquet Critica Care Ab with the FDA for Servo-air 4.0 Ventilator System.
| Device ID | K192604 |
| 510k Number | K192604 |
| Device Name: | Servo-air 4.0 Ventilator System |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Maquet Critica Care AB Röntgenvägen 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 | 2019-09-20 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17325710004248 | K192604 | 000 |
| 07325710011331 | K192604 | 000 |
| 07325710004906 | K192604 | 000 |
| 07325710004210 | K192604 | 000 |
| 07325710004166 | K192604 | 000 |
| 07325710004159 | K192604 | 000 |
| 07325710003909 | K192604 | 000 |
| 07325710003114 | K192604 | 000 |
| 07325710001189 | K192604 | 000 |