(239 days)
An electrical conductor applied to a patient's skin to transmit electrical signals at the body surface to a monitor for diagnosis of ailments by health professionals. The electrodes, without a lead wire or cable connected, are MR safe and not MRI compatible as a stand alone device.
Not Found
The provided text is an FDA 510(k) clearance letter for an ECG electrode (various) and the associated "Indications for Use" statement. It does not contain information on acceptance criteria, device performance, or details of a study to prove the device meets these criteria. This type of document is a regulatory approval, confirming substantial equivalence to a predicate device, rather than a scientific study report.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.