K032926 is an FDA 510(k) clearance for the EKG SPEAKS. This device is classified as a Analyzer, Pacemaker Generator Function, Indirect (Class II - Special Controls, product code KRE).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 15, 2003, 23 days after receiving the submission on September 22, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3640.
| 510(k) Number | K032926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2003 |
| Decision Date | October 15, 2003 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRE — Analyzer, Pacemaker Generator Function, Indirect |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3640 |