No. Clearance Date Oridion 1987 Medical Ltd / Oridion Medical 1987 Ltd. / Givony Regulatory Affairs Manager Oridion Medical 1987 Limited / K123690 Trade / Regulatory Affairs Oridion Medical 1987 Ltd / /
Country
Israel / /
Currency
pence / /
Event
FDA Phase / /
Facility
General Hospital / Hamarpe Street Har Hotzvim Industrial Park / Har Hotzvim Industrial Park / New Hampshire Avenue Document Control Center / / /
IndustryTerm
capnography software feature / announcements concerning your device / predicate devices / software feature / qualified healthcare personnel / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /
MedicalCondition
patient's pulmonary status / integrated pulmonary index / optimal pulmonary status / patient's pulmonary parameters / /
Organization
Division of Postmarket Surveillance / Food and Drug Administration / office of Device Evaluation / General Hospital / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Device Evaluation Center for Devices and Radiological Health Enclosure Response / CDRH’s office of Surveillance / M.S. Director Division of Anesthesiology / /
Person
Mary S. Runner / Silver Spring / Dalia Givony / Erin I. Keith / Todd D. Courtney / / /
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue