DISPOSABLE ELECTRODE #1900
Device Facts
| Record ID | K822798 |
|---|---|
| Device Name | DISPOSABLE ELECTRODE #1900 |
| Applicant | Andover Medical, Inc. |
| Product Code | DRX · Cardiovascular |
| Decision Date | Oct 15, 1982 |
| 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.
