The following data is part of a premarket notification filed by Ecotron Co., Ltd with the FDA for Anyview Dr Series Fpd Fluoroscopic Mobile C-arm Anyview-240dr, Anyview-320dr, Anyview-500dr.
| Device ID | K180473 |
| 510k Number | K180473 |
| Device Name: | ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | ECOTRON Co., Ltd Rm 504, Hanshin IT Tower II, 47, Digital-ro 9-gil Geumcheon-gu Seoul, KR 153-712 |
| Contact | Sang Bond Lee |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-22 |
| Decision Date | 2018-03-23 |
| Summary: | summary |