The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Universal-bodytest.
| Device ID | K843846 |
| 510k Number | K843846 |
| Device Name: | UNIVERSAL-BODYTEST |
| Classification | Plethysmograph, Pressure |
| Applicant | ERICH JAEGER, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCM |
| CFR Regulation Number | 868.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-01 |
| Decision Date | 1985-02-14 |