The following data is part of a premarket notification filed by Fujinon Inc. with the FDA for Fujinon Ultrasonic Processor.
| Device ID | K111243 |
| 510k Number | K111243 |
| Device Name: | FUJINON ULTRASONIC PROCESSOR |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FUJINON INC. 419 WEST AVENUE Stamford, CT 06902 |
| Contact | Katherine Y Choi |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-05-03 |
| Decision Date | 2011-05-16 |
| Summary: | summary |