The following data is part of a premarket notification filed by Erich Jaeger B.v. with the FDA for Modification To The Oxyconalpha.
| Device ID | K980094 |
| 510k Number | K980094 |
| Device Name: | MODIFICATION TO THE OXYCONALPHA |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | ERICH JAEGER B.V. REGULIERENING 11 Nl-3981 La Bunnik, NL Nl-3981 |
| Contact | Leo D Bakker |
| Correspondent | Leo D Bakker ERICH JAEGER B.V. REGULIERENING 11 Nl-3981 La Bunnik, NL Nl-3981 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-09 |
| Decision Date | 1998-07-28 |