The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Divan Anesthesia Ventilator.
| Device ID | K980208 |
| 510k Number | K980208 |
| Device Name: | DIVAN ANESTHESIA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | James J Brennan |
| Correspondent | James J Brennan DRAEGER MEDICAL, INC. 3135 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 | 1998-01-20 |
| Decision Date | 1998-08-04 |
| Summary: | summary |