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Hill-Rom VersaLet infant warmer/incubator 510(k) pending at FDA.

This article was originally published in The Gray Sheet

Executive Summary

HILL-ROM VERSALET INFANT WARMER/INCUBATOR LAUNCH is planned in the first half of 1998 pending 510(k) clearance of the product, the company says. The device, which combines the features of a radiant warmer with the those of an incubator, "eliminates transfers from infant warmers to incubators and back again, thus relieving a significant amount of physiological stress on the infant," the firm maintains. The Versalet, for which a 510(k) is under review at FDA, is intended for newborn care in the neonatal intensive care unit.
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