{"product_id":"fda-510k-k203689","title":"FDA 510(k) K203689, Tidepool Loop, by Tidepool Project","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eInteroperable Automated Glycemic Controller\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK203689\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Tidepool Loop\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Tidepool Project\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e862.1356\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eQJI\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e12\/17\/2020\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 01\/23\/2023\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eClinical Chemistry\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eClinical Chemistry\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 5,000\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 2,167\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 2,833\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221304484,"sku":"FDA510K203689","price":3500.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k203689","provider":"FOIA Document Source","version":"1.0","type":"link"}