The following data is part of a premarket notification filed by Drager Medizintechnik Gmbh with the FDA for Non-invasive Ventilation Niv Option, Model 84 14 474.
| Device ID | K010093 |
| 510k Number | K010093 |
| Device Name: | NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-11 |
| Decision Date | 2001-06-14 |