{"product_id":"fda-510k-k223213","title":"FDA 510(k) K223213, Tandem Mobi Insulin Pump with Interoperable Technology, by Tandem Diabetes Care, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eAlternate Controller Enabled Insulin Infusion Pump\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK223213\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Tandem Mobi Insulin Pump with Interoperable Technology\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Tandem Diabetes Care, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e880.573\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eQFG\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2022-10-17\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2023-07-10\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 1,500\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,430\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 70\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51315539345572,"sku":"FDA510K223213","price":273.7,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k223213","provider":"FOIA Document Source","version":"1.0","type":"link"}