The following data is part of a premarket notification filed by Drager Medical B.v. with the FDA for Oxylog 3000.
| Device ID | K062267 |
| 510k Number | K062267 |
| Device Name: | OXYLOG 3000 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER MEDICAL B.V. 3135 Quarry Road Telford, PA 18969 |
| Contact | Bryan Overton |
| Correspondent | Bryan Overton DRAGER MEDICAL B.V. 3135 Quarry Road 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 | 2006-08-04 |
| Decision Date | 2006-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675425670 | K062267 | 000 |
| 04048675425656 | K062267 | 000 |
| 04048675422174 | K062267 | 000 |