The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Medison 1500.
| Device ID | K924432 |
| 510k Number | K924432 |
| Device Name: | MEDISON 1500 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDISON CO., LTD. 5319 RANDALL PLACE Fremont, CA 94538 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook MEDISON CO., LTD. 5319 RANDALL PLACE 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 | 1992-09-01 |
| Decision Date | 1993-11-24 |