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NEW YORK HEART INSTRUMENTS, INC. SEEKING CLASS II STATUS FOR MODEL FFF-IA EKG

This article was originally published in The Gray Sheet

Executive Summary

NEW YORK HEART INSTRUMENTS, INC. SEEKING CLASS II STATUS FOR MODEL FFF-IA EKG device when labeled for "aiding physicians in making an early, noninvasive detection of coronary artery disease." In a recent petition, the company asks FDA to reconsider its decision to deny a 510(k) for the electrocardiogram device; the agency's conclusion was based on a determination that the product has a new indication that requires regulation in Class III.
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