{"product_id":"fda-510k-k220935","title":"FDA 510(k) K220935, Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App, by Iren-Medical, Ltd.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eSystem, Peritoneal, Automatic Delivery\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK220935\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Iren-Medical, Ltd.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.5630\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eFKX\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e03\/31\/2022\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 12\/29\/2022\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 2,682\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,640\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 1,042\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221664932,"sku":"FDA510K220935","price":2390.48,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k220935","provider":"FOIA Document Source","version":"1.0","type":"link"}