The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujinon/fujifilm Ultrasonic Endoscope Eb-530us.
| Device ID | K121035 |
| 510k Number | K121035 |
| Device Name: | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Contact | Gina Walljasper |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2012-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410333435 | K121035 | 000 |
| 04547410330182 | K121035 | 000 |
| 04547410111408 | K121035 | 000 |
| 04547410111392 | K121035 | 000 |
| 04547410104349 | K121035 | 000 |