The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujinon/fujifilm Eb-530 Series Bronchoscopes (eb-530s, Eb-530t And Eb-530h.
| Device ID | K122535 |
| 510k Number | K122535 |
| Device Name: | FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| 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 | 2012-08-20 |
| Decision Date | 2012-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410333312 | K122535 | 000 |
| 04547410330168 | K122535 | 000 |
| 04547410330151 | K122535 | 000 |
| 24547410132780 | K122535 | 000 |
| 14547410093299 | K122535 | 000 |
| 04547410093285 | K122535 | 000 |
| 04547410079074 | K122535 | 000 |
| 04547410079067 | K122535 | 000 |
| 04547410079036 | K122535 | 000 |