The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Medical Air Compressor, Model # 8413419.
| Device ID | K982789 |
| 510k Number | K982789 |
| Device Name: | MEDICAL AIR COMPRESSOR, MODEL # 8413419 |
| Classification | Compressor, Air, Portable |
| 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 | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-10 |
| Decision Date | 1998-10-29 |
| Summary: | summary |