K191692 is an FDA 510(k) clearance for the KardioScreen. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Imedrix Inc. (Formerly Piitech Inc.) (Milpitas, US). The FDA issued a Cleared decision on January 10, 2020, 199 days after receiving the submission on June 25, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K191692 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2019 |
| Decision Date | January 10, 2020 |
| Days to Decision | 199 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 |