The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Drager-vapor 19.1 W/plug System S Plus.
| Device ID | K981472 |
| 510k Number | K981472 |
| Device Name: | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | J. Teresa Dorriety |
| Correspondent | J. Teresa Dorriety DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-24 |
| Decision Date | 1998-05-07 |
| Summary: | summary |