The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Ergo-pneumotest.
| Device ID | K853434 |
| 510k Number | K853434 |
| Device Name: | ERGO-PNEUMOTEST |
| Classification | Computer, Oxygen-uptake |
| Applicant | ERICH JAEGER, INC. 5251 ZENITH PKWY. Rockford, IL 61111 |
| Contact | Ronald Evenson |
| Correspondent | Ronald Evenson ERICH JAEGER, INC. 5251 ZENITH PKWY. Rockford, IL 61111 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-15 |
| Decision Date | 1986-02-05 |