K183425 is an FDA 510(k) clearance for the CARDIOVIT AT-102 G2. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Schiller AG (Baar Zug, CH). The FDA issued a Cleared decision on March 2, 2020, 447 days after receiving the submission on December 11, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K183425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2018 |
| Decision Date | March 02, 2020 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |