The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Sonicomp.
| Device ID | K833488 |
| 510k Number | K833488 |
| Device Name: | SONICOMP |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | SONICAID, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-07 |
| Decision Date | 1983-11-28 |