Traditional 510(k) FEB LifeScan Europe / WelIDoc Inc. / WelDoc Inc. / Regulatory Affairs Lifescan Inc. / LifeScan Europe / In Vitro Diagnostics / HUMAN SERVICES Lifescan Inc. / Cilag GmbH International / /
Country
Switzerland / / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
Internet address http /
MedicalCondition
Device Diabetes / diabetes / /
MedicalTreatment
self-management / /
Organization
Division of Postmarket Surveillance / CDRFI's office of Surveillance / office of Compliance / Public Health Service Food and Dnug Administration / Toxicology Devices Office / Center for Devices / Chemistry and Toxicology Devices Office / Center for Devices and Radiological Health / Division of Cilag GmbH International Landis / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Division of Chemistry / /
Person
Andrea M. Tasker / Silver Spring / Strasse I Zug / Courtney H. Lias / Carol C.Benson / / /
Position
General / Director Regulatory Affairs / Director / Correspondent / /
Product
Apple iPhone 3GS Smartphone / Apple iPod Touch Portable Audio Device / iPad / Federal Food / /
ProgrammingLanguage
V / D / /
ProvinceOrState
Pennsylvania / /
Technology
radiation / SMS / operating systems / mobile devices / http / communication protocols / Bluetooth / /
OneTouch® Reveal Diabetes Management Application Confidential and Proprietary Information Sponsor Traditional 510(k)