K170182 is an FDA 510(k) clearance for the CARDIOVIT FT-1. 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 July 19, 2017, 177 days after receiving the submission on January 23, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K170182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2017 |
| Decision Date | July 19, 2017 |
| Days to Decision | 177 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 |