{"product_id":"fda-510k-k234055","title":"FDA 510(k) K234055, DEKA Loop, by Deka Research and Development","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eInteroperable Automated Glycemic Controller\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK234055\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e DEKA Loop\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Deka Research and Development\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\u003e2023-12-22\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2024-03-13\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 8,399\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 7,573\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 826\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309545390244,"sku":"FDA510K234055","price":1952.87,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k234055","provider":"FOIA Document Source","version":"1.0","type":"link"}