{"product_id":"fda-510k-k121319","title":"FDA 510(k) K121319, ZIO PATCH, by iRhythm Technologies, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eRecorder, Magnetic Tape, Medical\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK121319\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e ZIO PATCH\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e iRhythm Technologies, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e870.28\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eDSH\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2012-05-02\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2012-07-18\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 383\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 229\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 154\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51315379273892,"sku":"FDA510K121319","price":540.59,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k121319","provider":"FOIA Document Source","version":"1.0","type":"link"}