The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Eg-530ct, Eg-530d, Ec-530dl, And Es-530we Endoscopes.
| Device ID | K142629 |
| 510k Number | K142629 |
| Device Name: | EG-530CT, EG-530D, EC-530DL, And ES-530WE Endoscopes |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Contact | Mary Moore |
| Correspondent | Mary Moore FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Product Code | FDS |
| Subsequent Product Code | FAM |
| Subsequent Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2015-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410333305 | K142629 | 000 |
| 04547410333299 | K142629 | 000 |
| 04547410331639 | K142629 | 000 |
| 04547410330236 | K142629 | 000 |
| 04547410079159 | K142629 | 000 |