(327 days)
ECG monitoring electrodes for short term use (
Pregelled electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 70 mm in diameter or rectangular/square in shape. Electrodes are bulk packaged in OPP/PE laminated pouches; 60/pouch; 300/box.
The provided document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for ECG monitoring electrodes, detailing administrative information, device names, predicate devices, device description, and intended use, along with the FDA's letter of substantial equivalence. It does not provide performance data, study design, or methodology for assessing the device's performance against specific criteria.
§ 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.