The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Bronchoscope Model Eb-530p.
| Device ID | K171291 |
| 510k Number | K171291 |
| Device Name: | FUJIFILM Bronchoscope Model EB-530P |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Contact | Shraddha S. More |
| Correspondent | Shraddha S. More FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-02 |
| Decision Date | 2018-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14547410343202 | K171291 | 000 |