Zdrowie i gospodarka · 14/07/2006
FDA Denies IM Systems' Petitions for Device Reclassification
The FDA has denied IM Systems' petitions to reclassify their SleepCheck, ActiTrac, and PAM-RL devices from class II to class I, citing insufficient new information to demonstrate the safety and effectiveness of general controls.
Source: Federal Register — Food and Drug AdministrationOpen original release →