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 |