K112959 is an FDA 510(k) clearance for the CALG-STR EXERCISE ECG ANALYSIS ALGORITHM. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Philips Health Care (Thousand Oaks, US). The FDA issued a Cleared decision on January 26, 2012, 114 days after receiving the submission on October 4, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K112959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2011 |
| Decision Date | January 26, 2012 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS - Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |