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Zdrowie i gospodarka · 28.10.2003

Medical Devices; Reclassification of Automated External Defibrillators

The Food and Drug Administration (FDA) announces an opportunity to submit information and comments concerning FDA's intent to initiate a proceeding to reclassify automated external defibrillators (AEDs) from class III (premarket approval) to class II (special controls). AEDs are devices that deliver an electric shock to correct an arrhythmia.

Source: Federal Register — Food and Drug AdministrationOpen original release →