The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Atc Option For Evita 2 Dura And Evita 4.
| Device ID | K992608 |
| 510k Number | K992608 |
| Device Name: | ATC OPTION FOR EVITA 2 DURA AND EVITA 4 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-04 |
| Decision Date | 1999-08-24 |
| Summary: | summary |