{"product_id":"fda-510k-k213657","title":"FDA 510(k) K213657, DEEPVESSEL FFR, by Keyamed Na, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eCoronary Vascular Physiologic Simulation Software\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK213657\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e DEEPVESSEL FFR\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Keyamed Na, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e870.1415\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003ePJA\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e11\/19\/2021\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 04\/01\/2022\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 1,057\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 819\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 238\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221566628,"sku":"FDA510K213657","price":759.4,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k213657","provider":"FOIA Document Source","version":"1.0","type":"link"}