The following data is part of a premarket notification filed by Digisonics, Inc. with the FDA for Model Ob-500 Fetal Growth Analysis & Option Oblink.
| Device ID | K900271 |
| 510k Number | K900271 |
| Device Name: | MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | DIGISONICS, INC. 2401 PORTSMOUTH Houston, TX 77098 |
| Contact | Donna J Kanon |
| Correspondent | Donna J Kanon DIGISONICS, INC. 2401 PORTSMOUTH Houston, TX 77098 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-19 |
| Decision Date | 1990-04-19 |