The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Medison 4800.
| Device ID | K925582 |
| 510k Number | K925582 |
| Device Name: | MEDISON 4800 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 5319 RANDALL PL. Fremont, CA 94538 |
| Contact | Mark F Hayward |
| Correspondent | Mark F Hayward MEDISON AMERICA, INC. 5319 RANDALL PL. Fremont, CA 94538 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1994-12-27 |