K132068 is an FDA 510(k) clearance for the PHILIPS DXL 12/16-LEAD ECG ALGORITHM. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on September 26, 2013, 85 days after receiving the submission on July 3, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K132068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2013 |
| Decision Date | September 26, 2013 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |