The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Ergo-oxyscreen.
| Device ID | K843841 |
| 510k Number | K843841 |
| Device Name: | ERGO-OXYSCREEN |
| Classification | Spirometer, Diagnostic |
| Applicant | ERICH JAEGER, INC. P.O. BOX 10008 Rockford, IL 61131 |
| Contact | Ronald Evenson |
| Correspondent | Ronald Evenson ERICH JAEGER, INC. P.O. BOX 10008 Rockford, IL 61131 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-01 |
| Decision Date | 1984-12-27 |