(207 days)
The Cardio-Card system monitors heart mythms and reports ECGs, thythm conditions, ECG printouts, BCG measurements, NIBPs and patient demographic information (e.g. patient name, ssn, physician name, address, physician notes, test notes). The system stores the patient's data to computers for later easy retrieval from its database. The computers can be networked to allow sharing of the information also. Studies can be typical short 12-sec ECG strips and NIBPs or very long term studies.
Cardio-Card Management System II
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any criteria. The document is a 510(k) clearance letter from the FDA for the Cardio-Card Management System II, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters and indications for use but does not contain details about performance studies, acceptance criteria, or ground truth establishment.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).