The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Neoflow Option Model Numbers 8413563, 8411900.
| Device ID | K983219 |
| 510k Number | K983219 |
| Device Name: | NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER, INC. 3136 QUARRY RD. Telford, PA 18969 |
| Contact | Harald Kneuer |
| Correspondent | Harald Kneuer 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 | 1998-09-14 |
| Decision Date | 1998-12-07 |
| Summary: | summary |