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PubMed · 3273929

Disposable pressure transducers.

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Abstract

We evaluated twelve disposable pressure transducers from eleven manufacturers. All were rated Acceptable and were ranked in four groups. The first two groups had similar performance characteristics. Groups three and four were ranked primarily according to the effect of fluid spills and the ease of achieving accurate dynamic response.

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Disposable EquipmentEvaluation Studies as TopicHumansTransducersTransducers, PressureJournal Article

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1988. Disposable pressure transducers.. https://pubmed.ncbi.nlm.nih.gov/3273929/

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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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