The following data is part of a premarket notification filed by Erich Jaeger Gmbh with the FDA for Oxycon Mobile.
| Device ID | K023120 |
| 510k Number | K023120 |
| Device Name: | OXYCON MOBILE |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | ERICH JAEGER GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | Earl Draper |
| Correspondent | Earl Draper ERICH JAEGER GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-19 |
| Decision Date | 2003-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892905402 | K023120 | 000 |
| 04250892902685 | K023120 | 000 |
| 14250892903481 | K023120 | 000 |
| 14250892902361 | K023120 | 000 |
| 14250892906208 | K023120 | 000 |