The following data is part of a premarket notification filed by Axcan Scientific Corp. with the FDA for Augros Hysterometer.
| Device ID | K831224 |
| 510k Number | K831224 |
| Device Name: | AUGROS HYSTEROMETER |
| Classification | Sound, Uterine |
| Applicant | AXCAN SCIENTIFIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHM |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-15 |
| Decision Date | 1983-10-28 |