The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm 600 Series Endoscopes.
| Device ID | K132210 |
| 510k Number | K132210 |
| Device Name: | FUJIFILM 600 SERIES ENDOSCOPES |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR Wayne, NJ 07470 |
| Contact | Gina Walljasper |
| Correspondent | Gina Walljasper FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR Wayne, NJ 07470 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-16 |
| Decision Date | 2014-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410337396 | K132210 | 000 |
| 04547410331172 | K132210 | 000 |
| 04547410331073 | K132210 | 000 |
| 04547410331066 | K132210 | 000 |