This device is classified as import for export, therefore 510k is not applicable.Model fb-15v is available in the usa with a 510k number k951199.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ocular lens cloudy (not clear view).Based on the result, we concluded that it was caused due to the moisture condensation in the ocular lens.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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