The following data is part of a premarket notification filed by Draeget Medical Ag & Co. Kgaa with the FDA for Lpo Option For Drager Intensive Care Ventilator Savina.
| Device ID | K040642 |
| 510k Number | K040642 |
| Device Name: | LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGET MEDICAL AG & CO. KGAA 3135 Quarry Road Telford, PA 18969 |
| Contact | James J Brennan |
| Correspondent | James J Brennan DRAEGET MEDICAL AG & CO. KGAA 3135 Quarry Road 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 | 2004-03-11 |
| Decision Date | 2004-06-02 |
| Summary: | summary |