The following data is part of a premarket notification filed by Drager Medizintechnik Gmbh with the FDA for Oxylog 1000, Model 2m86840.
| Device ID | K010793 |
| 510k Number | K010793 |
| Device Name: | OXYLOG 1000, MODEL 2M86840 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER MEDIZINTECHNIK GMBH 3135 QUARRY RD. Telford, PA 18969 |
| Contact | James J Brennan |
| Correspondent | James J Brennan DRAGER MEDIZINTECHNIK GMBH 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 | 2001-03-16 |
| Decision Date | 2001-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675252313 | K010793 | 000 |