The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonoace 88 Portable Ultrasound Scanner.
| Device ID | K900505 |
| 510k Number | K900505 |
| Device Name: | SONOACE 88 PORTABLE ULTRASOUND SCANNER |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | MEDISON CO., LTD. 602 ST. ANDREWS DR. Media, PA 19063 |
| Contact | Robert D Waxham |
| Correspondent | Robert D Waxham MEDISON CO., LTD. 602 ST. ANDREWS DR. Media, PA 19063 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-02 |
| Decision Date | 1990-08-10 |