This device is not distributed in us so that unique identifier is blank.This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10 is available in the usa with a 510k number k131902.Since there are no defective parts,the medical device problem code,investigation findings are blank.Evaluation summary: it was caused due to the design specification depending on the customer's preference.It is not the product failure.This report is being filed as part of the pentax backlog management plan.
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