The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon/fujifilm Ultrasonic Endoscope Eg-530ur2 And Eg-530ut2.
| Device ID | K120446 |
| 510k Number | K120446 |
| Device Name: | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FUJINON, INC. 10 HIGH POINT DR. Wayne, NJ 07470 |
| Contact | Mark Job |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-02-14 |
| Decision Date | 2012-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410339437 | K120446 | 000 |
| 04547410339420 | K120446 | 000 |
| 04547410331578 | K120446 | 000 |
| 04547410331561 | K120446 | 000 |
| 24547410138515 | K120446 | 000 |