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 cfb (coherent fiber bundle) was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the cfb (coherent fiber bundle).In addition, our technician confirmed that the control body fluid damage, the ocular fluid damage, and the insertion flexible tube leak; however, these defects 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.
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