(179 days)
The Bio-Cybernetic Cardio Diagnostic System is intended to be used as an aid to diagnosis by means of analysis of the EKG waveform in the frequency domain (power spectral estimate).
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I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving the device meets those criteria. The document is solely a 510(k) clearance letter from the FDA to Clover Hi-Tech, Inc. for their Bio-Cybernetics Cardio-Diagnostic System. It confirms that the device has been found substantially equivalent to a legally marketed predicate device and lists the indications for use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given document.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).