{"product_id":"fda-510k-k181502","title":"FDA 510(k) K181502, Zio AT ECG Monitoring System, ZEUS System, by iRhythm Technologies, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eComputer, Diagnostic, Programmable\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK181502\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Zio AT ECG Monitoring System, ZEUS System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e iRhythm Technologies, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e870.1425\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eDQK\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e06\/07\/2018\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 08\/29\/2018\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eCardiovascular\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eCardiovascular\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 2,966\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 119\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 2,847\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313220812964,"sku":"FDA510K181502","price":3500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k181502","provider":"FOIA Document Source","version":"1.0","type":"link"}