The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Ultrasonic Endoscope And Processor, Models Eg-530ur, Eg-530ut And Su-700.
| Device ID | K063847 |
| 510k Number | K063847 |
| Device Name: | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FUJINON, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary FUJINON, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Product Code | FDS |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-27 |
| Decision Date | 2007-03-01 |
| Summary: | summary |