K113264 is an FDA 510(k) clearance for the ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE). This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Ld Technology, LLC (Miami, US). The FDA issued a Cleared decision on March 2, 2012, 119 days after receiving the submission on November 4, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K113264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2011 |
| Decision Date | March 02, 2012 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |