K051730 is an FDA 510(k) clearance for the MATRIX HOLTER SYSTEM, MODEL M12. This device is classified as a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II - Special Controls, product code MLO).
Submitted by Global Instrumentation, LLC (Manlius, US). The FDA issued a Cleared decision on September 26, 2005, 91 days after receiving the submission on June 27, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K051730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2005 |
| Decision Date | September 26, 2005 |
| Days to Decision | 91 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MLO - Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |