The following data is part of a premarket notification filed by Medical Soft, Inc. with the FDA for Babe Computer Pogram For Obstetric Ultrasound.
| Device ID | K942490 |
| 510k Number | K942490 |
| Device Name: | BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | MEDICAL SOFT, INC. 4724 LEYDEN WAY Ellicott City, MD 21042 -5989 |
| Contact | Mayumi M Hall |
| Correspondent | Mayumi M Hall MEDICAL SOFT, INC. 4724 LEYDEN WAY Ellicott City, MD 21042 -5989 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-25 |
| Decision Date | 1995-02-15 |