(87 days)
The ECG electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for resting ECG.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Blue Sensor SUPtab ECG Electrode." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the provided text DOES NOT contain specific information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- The FDA's determination of substantial equivalence (K983689).
- The regulatory classification of the device (Class II).
- The general controls provisions of the Act that apply.
- The allowed indications for use (transmitting electrical signals for ECG/vectorcardiogram, for single patient use, designed for resting ECG).
- Contact information for further regulatory advice.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, etc.) from this document. This kind of detail would typically be found in the 510(k) submission itself, which is not provided here.
§ 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.