The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Endoscopic Co2 Regulator Gw-100.
| Device ID | K180711 |
| 510k Number | K180711 |
| Device Name: | FUJIFILM Endoscopic CO2 Regulator GW-100 |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 40 Boroline Road Allendale, NJ 07401 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-19 |
| Decision Date | 2018-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410366051 | K180711 | 000 |
| 04547410366037 | K180711 | 000 |