Vectorcardiograph
The Vectorcardiograph is a cardiovascular diagnostic device that records the magnitude and direction of the heart's electrical forces as a continuous loop in three-dimensional space, providing a more detailed picture of cardiac electrical activity than a standard ECG. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYC and the applicable regulation is 21 CFR 870.2400, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DYC
- Device Class
- FDA class 2
- Regulation Number
- 870.2400
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023414 | MIDA ALGORITHM REV. B | Dec 05, 2003 | Substantially Equivalent | Ortivus AB |
| K896396 | MIDA SYSTEM, MODELS 1000/1100 | Jan 18, 1990 | Substantially Equivalent | Medical Graphics Corp. |
| K823934 | CARIEL F12 | Dec 16, 1983 | Substantially Equivalent | Odam |
| K810529 | DIRECT WRITING VECTORCARDIOGRAPH | Apr 23, 1981 | Substantially Equivalent | Elmed, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.