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Michael Righter Principal Regulatory Affairs Righter Consulting Group LLC PO Box 63 Tolovana Park Oregon 97145 Re K170874 Trade/Device Name Eko Model E5 System EME5 Eko Duo Regulation Number 21 CFR 870. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for...
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What is eko devices inc?
Eko Devices Inc is a medical device company that specializes in creating digital stethoscopes and cardiac monitoring solutions.
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Eko Devices Inc is required to file their financial and operational information with the appropriate regulatory bodies and tax authorities.
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