This device is classified as import for export, therefore 510k is not applicable.Model eg-1690k is available in the usa with a 510k number k131902.We checked the returned unit and confirmed the ccd module as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the angle wire cut, the insertion flexible tube (ift) inside spiral closer condition, the light guide cable worn out, lg prong top perforated, and the lg prong top loosened; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
|