This device is classified as import for export, therefore 510k is not applicable.Model fb-18v 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 fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ocular.In addition, our technician confirmed that the angle wire fluid damage, the objective lens broken, the segment corroded, the objective gluing missing, the segment steel braid deformed, the insertion flexible tube leak, the lg prong top dirty, the lcb distal cover glass dirty, the bending rubber gluing poor finish, and the root brace rubber (insertion flexible tube) flared; 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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