The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujifilm Endoscopic Co2 Regulator.
| Device ID | K133976 |
| 510k Number | K133976 |
| Device Name: | FUJIFILM ENDOSCOPIC CO2 REGULATOR |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Contact | Gina Walljasper |
| Correspondent | Gina Walljasper FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-26 |
| Decision Date | 2014-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410331608 | K133976 | 000 |
| 04547410331592 | K133976 | 000 |
| 04547410331585 | K133976 | 000 |