The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Servo-u Ventilator System, Servo-n Ventilator System.
| Device ID | K151814 |
| 510k Number | K151814 |
| Device Name: | SERVO-U Ventilator System, SERVO-n Ventilator System |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | MAQUET CRITICAL CARE AB RONTGENVAGEN 2 Solna, SE Se-171 54 |
| Contact | Maria Von Bahr |
| Correspondent | Lia Gonzalez MAQUET MEDICAL SYSTEMS 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 | 2015-07-06 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07325710009796 | K151814 | 000 |
| 07325710000717 | K151814 | 000 |
| 07325710000670 | K151814 | 000 |
| 07325710000663 | K151814 | 000 |
| 07325710000304 | K151814 | 000 |
| 07325710000250 | K151814 | 000 |
| 17325710004200 | K151814 | 000 |
| 17325710004149 | K151814 | 000 |
| 17325710004132 | K151814 | 000 |
| 07325710002742 | K151814 | 000 |
| 17325710002572 | K151814 | 000 |
| 17325710002190 | K151814 | 000 |
| 07325710000724 | K151814 | 000 |
| 07325710000748 | K151814 | 000 |
| 07325710000762 | K151814 | 000 |
| 07325710005705 | K151814 | 000 |
| 07325710004289 | K151814 | 000 |
| 07325710004265 | K151814 | 000 |
| 07325710004258 | K151814 | 000 |
| 07325710004180 | K151814 | 000 |
| 07325710002971 | K151814 | 000 |
| 07325710002889 | K151814 | 000 |
| 07325710002711 | K151814 | 000 |
| 07325710001110 | K151814 | 000 |
| 07325710001042 | K151814 | 000 |
| 07325710000786 | K151814 | 000 |
| 17325710001971 | K151814 | 000 |