The following data is part of a premarket notification filed by Erich Jaeger B.v. with the FDA for Oxycon Pro.
| Device ID | K992214 |
| 510k Number | K992214 |
| Device Name: | OXYCON PRO |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | ERICH JAEGER B.V. REGULIERENING 11 Nl-3981 La Bunnik, NL Nl-3981 |
| Contact | Leo Den Bakker |
| Correspondent | Leo Den Bakker ERICH JAEGER B.V. REGULIERENING 11 Nl-3981 La Bunnik, NL Nl-3981 |
| Product Code | BZC |
| Subsequent Product Code | DPS |
| Subsequent Product Code | MLC |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-01 |
| Decision Date | 2000-02-22 |