This device is classified as import for export, therefore 510k is not applicable.Model eb-1570k is available in the usa with a 510k number k131028 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 objective lens broken, the insertion flexible tube (ift) buckled, the lg cable connector corroded, the operation channel leakage, and the distal body worn out; 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.
|