The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device.
| Device ID | K103625 |
| 510k Number | K103625 |
| Device Name: | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Draeger Medical Systems, Inc. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy Draeger Medical Systems, Inc. 3135 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 | 2010-12-10 |
| Decision Date | 2011-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675249221 | K103625 | 000 |