K231160 is an FDA 510(k) clearance for the Cardio Q50, Cardio Q70. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Bionet Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 15, 2023, 238 days after receiving the submission on April 21, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K231160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2023 |
| Decision Date | December 15, 2023 |
| Days to Decision | 238 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 |