{"product_id":"fda-510k-k223846-ilet-ace-pump","title":"FDA 510(k) K223846, iLet® ACE Pump, by Beta Bionics, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K223846\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e iLet® ACE Pump\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Beta Bionics, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Alternate Controller Enabled Insulin Infusion Pump\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e QFG\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 12\/20\/2022 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 05\/19\/2023\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Clinical Chemistry","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429461164196,"sku":"FDA510K223846","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k223846-ilet-ace-pump","provider":"FOIA Document Source","version":"1.0","type":"link"}