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PubMed · 7192749

Disposable (infant) surface electrocardiogram electrodes in urodynamics: a simultaneous comparative study of electrodes.

D M Barrett
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Abstract

Substantiated by the simultaneous comparison with wire and rectal catheter electrodes, disposable surface electrocardiogram electrodes developed for infants have proved to be easy to place, well tolerated and reliable for urodynamic testing in more than 400 clinical urodynamic evaluations.

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Disposable EquipmentElectrocardiographyElectrodesElectromyographyEvaluation Studies as TopicHumansMaleMuscle ContractionUrethraUrination DisordersUrodynamicsComparative StudyJournal Article

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D M Barrett. 1980. Disposable (infant) surface electrocardiogram electrodes in urodynamics: a simultaneous comparative study of electrodes.. https://doi.org/10.1016/s0022-5347(17)55602-5

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PubMed2006

Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

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