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device）との実質的同等性を示すことにより市販が認められる審査区分であり、クラスIIIに適用される市販前承認（PMA）に比べて簡便な手続きとなっています。","claude-sonnet-5","33e7c531ba538f86b4c295ae74450a8168f4f25c3c4c84543887576a31e6abec","2026-08-24T03:40:21.731962+00:00",{"product_code":6,"summary_ja":128,"stats":129,"stats_hash":138,"model_name":124,"created_at":139,"updated_at":139},"本製品コードにおける510(k)の累計件数は1件で、参入企業数は1社、直近5年間の件数も1件となっています。不具合報告および回収については、いずれも累計件数が0件であり、確認されていません。",{"pma":130,"k510":131,"as_of":133,"events":134,"recalls":135,"top_problems":137},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":26,"latest":132,"applicants":26},"2026-02-06","2026-08",{"death":24,"other":24,"total":24,"injury":24,"last5y":24,"malfunction":24,"latest_month":25},{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":136},[],[],"76f9b9ef8ba93f33e8d662af6a3cc0c3aeeadbec3106c987b7a280ed32b55a4c","2026-08-24T05:23:16.025025+00:00",{"items":141,"total":24},[],{"items":143,"total":26},[144],{"k_number":18,"device_name":145,"applicant":146,"decision_date":132,"clearance_type":147,"decision_code":148,"statement_or_summary":25},"Amferia 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