insulin bolus calculator algorithm / Wireless Capability No Yes / healthcare professionals / control solutions / bolus calculator algorithm / announcements concerning your device / predicate device / manufacturing practice requirements / Internet address hLt /
MedicalCondition
diabetes / therapy Diabetes / pump User Group Diabetes / /
MedicalTreatment
insulin pump / /
Organization
mg/dL Intravenous administration / Division of Small Manufacturers / syringe/pen administration / Intravenous administration / Radiological Healthm Center for Devices and Radiological Health / FDA / Main Integrated Circuit Board / DEPARTMENT OF HEALTH / Division of Chemistry / Division of Postmarkct Surveillance / Chemistry and Toxicology Devices Office / /
Person
Aviva Plus / Aviva Plus Test / Lot-Release Criteria Identical / Courtney H. Lias / Nate Carrington / Aviva Combo / / /
Position
Expert meter Bolus Advisor / ACCU-CHEK Bolus Advisor / Director / Bolus Advisor / physician / /
Product
Federal Food / /
Technology
Expert System / radiation / fundamental scientific technology / insulin bolus calculator algorithm / Bluetooth / bolus calculator algorithm / Integrated Circuit / /
510(k) Summary Introduction According to the requirements of 21 CFR[removed], the following informiation provides sufficient detail to understand the basis for a determination of substantial equivalence. 1. Submitter Name