K023414 is an FDA 510(k) clearance for the MIDA ALGORITHM REV. B. This device is classified as a Vectorcardiograph (Class II - Special Controls, product code DYC).
Submitted by Ortivus AB (Taby, SE). The FDA issued a Cleared decision on December 5, 2003, 420 days after receiving the submission on October 11, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2400.
| 510(k) Number | K023414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2002 |
| Decision Date | December 05, 2003 |
| Days to Decision | 420 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYC — Vectorcardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2400 |