The following data is part of a premarket notification filed by Drager Medizintechnik Gmbh with the FDA for Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072.
| Device ID | K023289 |
| 510k Number | K023289 |
| Device Name: | OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER MEDIZINTECHNIK GMBH 3136 QUARRY RD. Telford, PA 18969 |
| Contact | James J Brennan |
| Correspondent | James J Brennan DRAGER MEDIZINTECHNIK GMBH 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 | 2002-10-02 |
| Decision Date | 2003-01-15 |
| Summary: | summary |