{"product_id":"fda-510k-k210365","title":"FDA 510(k) K210365, Second Opinion, by Pearl, Inc.","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eAnalyzer, Medical Image\u003cbr\u003e\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK210365\u003cbr\u003e\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Second Opinion\u003cbr\u003e\u003cstrong\u003eApplicant:\u003c\/strong\u003e Pearl, Inc.\u003cbr\u003e\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e892.207\u003cbr\u003e\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eMYN\u003cbr\u003e\u003cstrong\u003eDate Received: \u003c\/strong\u003e02\/08\/2021\u003cbr\u003e\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 03\/04\/2022\u003cbr\u003e\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eRadiology\u003cbr\u003e\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eRadiology\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 9,542\u003cbr\u003e\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 5,256\u003cbr\u003e\u003cstrong\u003eContent pages:\u003c\/strong\u003e 4,286\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51308063195300,"sku":"FDA510K210365","price":3500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k210365","provider":"FOIA Document Source","version":"1.0","type":"link"}