The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Evita 4 (8411900).
| Device ID | K980642 |
| 510k Number | K980642 |
| Device Name: | EVITA 4 (8411900) |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER, INC. 3136 QUARRY RD. Telford, PA 18969 |
| Contact | Harald Kneuer |
| Correspondent | Harald Kneuer DRAGER, INC. 3136 QUARRY RD. Telford, PA 18969 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-19 |
| Decision Date | 1998-09-04 |
| Summary: | summary |