K122483 Trade / Animas Corporation / M.B.A. / Asante Solutions Inc. / Submitter Information Company / /
Event
FDA Phase / /
Facility
General Hospital / New Hampshire Avenue Document control Center / /
IndustryTerm
announcements concerning your device / medical devices / software validation / manufacturing practice requirements / unchanged technology / marketed predicate devices / cleared device / manufacturing practice / Internet address http /
MedicalCondition
diabetes mellitus / altitude shock / MS / /
MedicalTreatment
insulin delivery / /
Organization
Division of Postmarket Surveillance / DEPARTMENT OF HEALTHI / Division of Anesthesiology / Device Evaluation Center for Devices and Radiological Health Enclosure Special / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Infection Control and Dental Devices Office / General Hospital / Division of Anestheelalogy / Division of Small Manufacturers / International and Consumer Assistance / /
Person
Silver Spring / Bush / / /
Position
Project Manager / Regulatory Affairs / Director / Manager August / Regulatory Project Manager / controller / /
Product
Federal Food / /
ProgrammingLanguage
Java / /
ProvinceOrState
Maryland / California / /
TVStation
KetG / /
Technology
Design verification / radiation / fundamental scientific technology / /
Special 510O(k) August 10, 2012 Asante Solutions Inc. Pearl-m Diabetes Management System