ZIPPREP ELECTRODE
Device Facts
| Record ID | K940802 |
|---|---|
| Device Name | ZIPPREP ELECTRODE |
| Applicant | Aspect Medical Systems, Inc. |
| Product Code | DRX · Cardiovascular |
| Decision Date | Jun 22, 1994 |
| 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.
