K102513 Trade / ResMed Limited C / Medical &Regulatory Affairs ResMed Corp. / /
Currency
BZD / /
Facility
General Hospital / /
IndustryTerm
Internet address htp/wwfagvMdcleie/eorefro/nutydfuthm Sincerely / test protocols / micro-processor / announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / electrical equipment / cleared predicate devices / respiratory humidification systems / manufacturing process / /
MedicalCondition
Obstructive Sleep Apnea / Apnea / Sleep Apnea / /
MedicalTreatment
IPPB / /
Organization
Division of Postmarket Surveillance / Division of Anesthesiology / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Infection Control and Dental Devices Office / CDRI's office of Surveillance / General Hospital / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /
Person
David D'Cruz / Silver Spring / Anthony D. Watson / / /
Position
Vice President Clinical / Director / humidifier and heater controller / V.P. / General / /
ProgrammingLanguage
J / K / /
ProvinceOrState
Maryland / California / /
Technology
radiation / Similar technologies / micro-processor / simulation / test protocols / /
S9 VPAP ST Traditional 51o(k) Submission ResMed 510(k) Summary