Evaluation summary: this device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.We checked the returned unit and confirmed that the ccd image failure.Based on the result, we concluded that it was caused due to the leakage occurred in the ccd module.In addition, we confirmed that the air/water nozzle clogged; however, it is not related to the alleged complaint.Based on the technical report, it was evaluated to submit mdr.
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