The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Babylog 8000 Infant Ventilator.
| Device ID | K903089 |
| 510k Number | K903089 |
| Device Name: | BABYLOG 8000 INFANT VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER, INC. 101 TECHNOLOGY DR. P.O. BOX 120 Pittsburgh, PA 15230 |
| Contact | Stefan Frembgen |
| Correspondent | Stefan Frembgen DRAGER, INC. 101 TECHNOLOGY DR. P.O. BOX 120 Pittsburgh, PA 15230 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-13 |
| Decision Date | 1991-06-10 |