The following data is part of a premarket notification filed by Ecotron Co.,ltd with the FDA for Anyview-500r Fluoroscopic Mobile X-ray System.
| Device ID | K160279 |
| 510k Number | K160279 |
| Device Name: | ANYVIEW-500R Fluoroscopic Mobile X-Ray System |
| 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 Bong 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 | 2016-02-02 |
| Decision Date | 2016-10-14 |
| Summary: | summary |