K133997 Trade / Device Identification Trade / LG Electronics / Intel / Microsoft / /
Country
Korea / / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
patient device / data collection software functionality / server software / medical devices / application software stores / predicate device / manufacturing practice requirements / sensor software / communication protocol / software specifications / wireless interference / manufacturing practice / Internet address http /
OperatingSystem
Android / Microsoft Windows / /
Organization
Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Cardiovascular Devices Office / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / CDRH’s office of Surveillance / Center for Devices and Radiological Health / Device Evaluation Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / /
Person
Bram D. Zuckerman / Silver Spring / Melissa A. Torres / Diane Sudduth / Hee Lee / / /
Position
Consultant / Director Division / Chief Research Engineer / Submission Correspondent / nurse / /
Product
SHA256 / /
ProvinceOrState
Texas / Maryland / /
Technology
radiation / Smart phone / smartphone / MAC address / Interface Device / Android / operating system / mobile device / SSL / Encryption / cellular telephone / video conferencing / smartphones / using SHA256 bit encryption / communication protocol / Bluetooth / /
Microsoft Word - Attachment 1 - 510k Summary.docx