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Insulet Corporation

FDA 510(k) & PMA Approved Dispositivos — 19 products

Total de dispositivos19
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K261461 Omnipod 6 algorithmQJI2026-06-29 Ver
510(k) K251779 Omnipod 5 algorithmQJI2025-12-03 Ver
510(k) K241777 SmartAdjust™ TechnologyQJI2024-08-26 Ver
510(k) K232741 Tecnologia SmartAdjust(TM)QJI2024-05-29 Ver
510(k) K231824 SmartBolus CalculatorQRX2023-10-18 Ver
510(k) K231826 Omnipod 5 ACE PumpQFG2023-10-18 Ver
510(k) K223372 Omnipod GO Insulin Delivery DeviceLZG2023-04-24 Ver
510(k) K220394 Tecnologia SmartAdjust(TM)QJI2022-08-19 Ver
510(k) K222239 SmartBolus CalculatorQRX2022-08-19 Ver
510(k) K203772 Omnipod 5 SmartBolus CalculatorQRX2022-01-27 Ver
510(k) K203774 SmartAdjust technologyQJI2022-01-27 Ver
510(k) K203768 Omnipod 5 ACE Pump (Pod)QFG2022-01-27 Ver
510(k) K211575 Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG2021-08-13 Ver
510(k) K192659 Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG2019-10-21 Ver
510(k) K191679 Omnipod DASH Insulin Management System with interoperable technologyQFG2019-09-20 Ver
510(k) K182630 Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG2019-01-08 Ver
510(k) K180045 Omnipod DASH Insulin Management SystemLZG2018-06-01 Ver
510(k) K162296 OmniPod Insulin Management SystemLZG2017-04-18 Ver
510(k) K160252 OmniPod Insulin Management SystemLZG2016-04-27 Ver
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