The following data is part of a premarket notification filed by Solomon Technology Labs with the FDA for Abacus Ob Ultrasoung Computer Software.
| Device ID | K951393 |
| 510k Number | K951393 |
| Device Name: | ABACUS OB ULTRASOUNG COMPUTER SOFTWARE |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | SOLOMON TECHNOLOGY LABS 2726 WEST MONTGOMERY DR. Chandler, AZ 85224 |
| Contact | Danzil K Solomon |
| Correspondent | Danzil K Solomon SOLOMON TECHNOLOGY LABS 2726 WEST MONTGOMERY DR. Chandler, AZ 85224 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-05-01 |