{"product_id":"fda-510k-k231675","title":"FDA 510(k) K231675, OneRF Ablation System, by Neuroone Medical Technologies Corp.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eGenerator, Lesion, Radiofrequency\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK231675\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e OneRF Ablation System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Neuroone Medical Technologies Corp.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e882.44\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eGXD\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2023-06-08\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2023-12-06\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eNeurology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eNeurology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 6,783\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 5,920\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 863\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51315539411108,"sku":"FDA510K231675","price":2028.82,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k231675","provider":"FOIA Document Source","version":"1.0","type":"link"}