Company: Respironics California Inc Date of Enforcement Report:5/10/2006 Class:l PRODUCT Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. It utilizes an internal compressor to generate compressed air for delivery to the...Read More

Company:Baxter Healthcare Corporation, Date of Enforcement Report:5/10/2006 Class:lI PRODUCT a) RenalSoft Observational Study v.2.0 – HD Module, PD Module and Medical Record Module; clinical data management software, Recall # Z-0831-06; b) RenalSoft v.1.1 – PD Module; clinical data management software, Recall # Z-0832-06; c) Renal Software Suite v.3.1 – HD Module; clinical data management software,...Read More