{"product_id":"fda-510k-k213134","title":"FDA 510(k) K213134, Accu-Chek Solo micropump system with interoperable technology, by Roche Diabetes Care GmbH","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\u003eK213134\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Accu-Chek Solo micropump system with interoperable technology\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Roche Diabetes Care GmbH\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\u003e2021-09-27\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2023-08-10\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 1,319\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 181\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51315539280036,"sku":"FDA510K213134","price":636.43,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k213134","provider":"FOIA Document Source","version":"1.0","type":"link"}