The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Edu System.
| Device ID | K894763 |
| 510k Number | K894763 |
| Device Name: | FUJINON EDU SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | FUJINON, INC. SUITE 750 2001 L STREET, N.W. Washington, DC 20036 |
| Contact | Matthew J Marks |
| Correspondent | Matthew J Marks FUJINON, INC. SUITE 750 2001 L STREET, N.W. Washington, DC 20036 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1990-05-22 |