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.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the objective lens cloudy (not clear view).Based on the result, we concluded that it was caused due to the moisture condensation in the objective lens.In addition, our technician confirmed that the distal body broken, the lcb (light carrying bundle) broken, the u/d lock lever broken, and the angle lever trim cap missing; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
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