MLN · Electrode, Electrocardiograph, Multi-Function
Cardiovascular · 21 CFR 870.2360 · Class 2
Overview
| Product Code | MLN |
|---|---|
| Device Name | Electrode, Electrocardiograph, Multi-Function |
| Regulation | 21 CFR 870.2360 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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.
Classification Rationale
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.
Special Controls
*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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
