K810529 is an FDA 510(k) clearance for the DIRECT WRITING VECTORCARDIOGRAPH. This device is classified as a Vectorcardiograph (Class II - Special Controls, product code DYC).
Submitted by Elmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981, 56 days after receiving the submission on February 26, 1981.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2400.
| 510(k) Number | K810529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1981 |
| Decision Date | April 23, 1981 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYC — Vectorcardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2400 |