Manufacturer EnviteC-Wismar GmbH / Honeywell EnviteC-Wismar GmbH / Company Philips Medical Systems / Covidien / Nellcor N-395 K122290 Envitec MySign PC Software / HP / K133064 Trade / EnviteC MySign@ PC Software (new version to support MySign S) EnviteC MySign@ PCt Software / EnviteC-Wismar GmbH / EnviteC-Wismar GmnbH / Medical Device Software / OxiPen Pulse Neilcor N395 Pulse Manufacturer EnviteC-Wismar GmbH / Microsoft.NET / Microsoft / Honeywell Nellcor Inc / /
Country
United States / / /
Event
FDA Phase / /
Facility
Avenue Document Control center / General Hospital / / /
IndustryTerm
portable applications / announcements concerning your device / predicate devices / software validation / alarm systems / medical electrical equipment / manufacturing practice requirements / listed predicate devices / adult and pediatric applications / risk management / marketed predicate devices / manufacturing practice / Internet address http /
MedicalCondition
Pus / /
OperatingSystem
XP / Microsoft Windows / /
Organization
Division of Postmarket Surveillance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / FDA / General Hospital / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / CDRH's office of Surveillance / M.S. Acting Director Division of Anesthesiology / /
MAY[removed]P 330U~ Page 1 of[removed]k) Summary in accordance with 21 CFR[removed]