In Brief: New York Heart Instruments
This article was originally published in The Gray Sheet
Executive Summary
New York Heart Instruments: 510(k) clearance of NYHI's Model FFF-IA electrocardiogram device on May 10 resolves dispute with FDA over the appropriate classification for the product. The company filed a petition with the agency last fall seeking Class II status after being told that the indication for which it was seeking clearance -- "early, noninvasive detection of coronary heart disease" -- precluded a substantial equivalence determination ("The Gray Sheet" Nov. 28, 1994, p. 14)...You may also be interested in...
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