K152043 is an FDA 510(k) clearance for the Diagnostic Station DS20. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on May 6, 2016, 288 days after receiving the submission on July 23, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K152043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2015 |
| Decision Date | May 06, 2016 |
| Days to Decision | 288 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 |