The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Evita 4.
| Device ID | K961687 |
| 510k Number | K961687 |
| Device Name: | EVITA 4 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly, VA 22021 |
| Contact | Harald Kneuer |
| Correspondent | Harald Kneuer DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly, VA 22021 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-01 |
| Decision Date | 1996-12-13 |
| Summary: | summary |