K102182 Trade / Regulatory Affairs Maquet Inc / GE / Maquet Critical Care AB / MAQUET GETINGE GROUP / Name & Address Maquet Critical Care AB / /
Country
United States / /
Event
FDA Phase / /
Facility
General Hospital / / /
IndustryTerm
gas flow / so-called gas modules / gas modules passes / toucliscreen technology / circle systems / exhaled gas returning / predicate device / fundamental technology / fresh gas settings / limited reporting device / software-controlled circle system / volume reflector technology / gas concentrations / manufacturing practice / Internet address / exhaled gas / subject device / constant fresh gas flow / healthcare professionals / fresh gas flow / flow transducer technology / announcements concerning your device / predicate devices / stored gas mixture / requested breathing gas / fresh gas / gas modules / gas mixture / marketed predicate devices / medical manufacturing / exhaled gas mixture / reflector gas module / set fresh gas flow / /
Organization
Division of Postmarket Surveillance / M.B.A. Director Division of Anesthesiology / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / ~d.ivMdcleiesSft/e~rarbe/eal~t office of Surveillance / Center for Devices and Radiological Health / FDA / General Hospital / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / HUMAN SERVICES F~ood and Drug Administration / /
Person
Karl-Yngve Keck / Whitney Tdrning / / /
Position
Torning Director / Director / CIo / /
Product
Flow-I Anesthesia System / Isoflurane / Sevoflurane / Federal Food / T6ming / /
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