Company: Cardinal Health NeuroCare Division Date of Enforcement Report 10/22/2008 Class:ll PRODUCT NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report 10/22/2008 Class:lll PRODUCT a) Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF;...Read More