DYC · Vectorcardiograph
Cardiovascular · 21 CFR 870.2400 · Class 2
Overview
| Product Code | DYC |
|---|---|
| Device Name | Vectorcardiograph |
| Regulation | 21 CFR 870.2400 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023414 | MIDA ALGORITHM REV. B | Ortivus AB | Dec 5, 2003 | SESE |
| K896396 | MIDA SYSTEM, MODELS 1000/1100 | Medical Graphics Corp. | Jan 18, 1990 | SESE |
| K823934 | CARIEL F12 | Odam | Dec 16, 1983 | SESE |
| K810529 | DIRECT WRITING VECTORCARDIOGRAPH | Elmed, Inc. | Apr 23, 1981 | SESE |
Top Applicants
- Elmed, Inc. — 1 clearance
- Medical Graphics Corp. — 1 clearance
- Odam — 1 clearance
- Ortivus AB — 1 clearance
