The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Babylog 8000 Plus.
| Device ID | K974176 |
| 510k Number | K974176 |
| Device Name: | BABYLOG 8000 PLUS |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER, INC. 3136 QUARRY RD. Telford, PA 18969 |
| Contact | Harald Kneuear |
| Correspondent | Harald Kneuear DRAGER, INC. 3136 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 | 1997-11-06 |
| Decision Date | 1998-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675448853 | K974176 | 000 |
| 04048675000099 | K974176 | 000 |
| 04048675000983 | K974176 | 000 |