K120168 Trade / ElAetric Co. / General Electric Co. / Lullaby TmLED Phototherapy System / GE Healthcare / Wipro GE Healthcare Private Ltd. / HUMAN SERVICES Wipro GE Healthcare Private Ltd. / /
Country
India / /
Event
FDA Phase / /
Facility
General Hospital / / /
IndustryTerm
healthcare practitioner / predicate device / verification testing protocols / manufacturing practice requirements / announcements concerining your device / Internet address http /
Division of Postmarket Surveillance / Phototherapy Device Neonatal Phototherapy Unit / Division of Anesthesiology / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Infection Control and Dental Devices Office / General Hospital / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / M.B.A. Division of Anesthesiology / CDRH's office of Surveillance / /
Person
Silver Spring / Agata Anthony / / /
Position
MAY LullabyT LED Phototberapy System GENERAL / Director Ohmneda Medical Regulatory Affairs / General / nIII l&niuion oI General / /
Product
Lullab yTM Phototherapy System (K07 1828) / Federal Food / /
ProvinceOrState
Maryland / /
Technology
Design verification / system design verification protocols / radiation / http / same fundamental scientific technology / Design verification testing protocols / midi / /
Premarket Notification .510(k) Summary As required by section[removed]MAY LullabyT LED Phototberapy System