The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Portable Medical Ultrasound Scanner.
| Device ID | K800434 |
| 510k Number | K800434 |
| Device Name: | PORTABLE MEDICAL ULTRASOUND SCANNER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BION ENT., LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-27 |
| Decision Date | 1980-04-10 |