{"product_id":"fda-510k-k131908","title":"FDA 510(k) K131908, 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC), by Fresenius Medical Care Renal Therapies Group, LLC","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eDialyzer, High Permeability With Or Without Sealed Dialysate System\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK131908\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Fresenius Medical Care Renal Therapies Group, LLC\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.5860\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eKDI\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e06\/26\/2013\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 10\/11\/2013\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 4,206\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 3,623\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 583\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51310822228132,"sku":"FDA510K131908","price":1461.02,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k131908","provider":"FOIA Document Source","version":"1.0","type":"link"}