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FDA 510(k) & PMA Approved Devices — 1 products

Total Devices1
Categories1
Latest FDA decision2026-09-11
TypeNumberDevice NameCodeDateActions
510(k) K254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)MWJ2026-09-11 View