Equlvaleft Inova Labs Inc. / Labs Inc. / Inova Labs Inc. / Product Name Respironics Inc. / /
Event
FDA Phase / /
Facility
General Hospital / /
IndustryTerm
subject device / portable device / aforementioned predicate devices / announcements concerning your device / predicate devices / predicate device / Internet address htp //wwwv~ / manufacturing practice requirements / predicate systems / travel environment / marketed predicate devices / manufacturing practice / Internet address Also / prescriptive device / stationary device / search existing data sources / cleared predicate devices / software testing / /
Organization
Center for Devices and Radiological Health / New Hampshire Avenue Docuwnent Contol Center / Base Unit / Activox DUO / FDA / General Hospital / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH's office of Surveillance / M.S. Director Division of Anesthesiology / /
Person
Keith / Ron Yarbrough / / /
Position
Prime Minister / Vice President of Regulatory Affairs and Quality Assurance / Vice President / Regulatory Affairs & Quality Control 3500 Comsouth Drive / /
K132205 Submitter: Inova Labs, Inc.