APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)
Device Facts
| Record ID | K864260 |
|---|---|
| Device Name | APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) |
| Applicant | Grandcor Medical Systems |
| Product Code | DRX · Cardiovascular |
| Decision Date | May 11, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2360 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
