K230111 is an FDA 510(k) clearance for the CORE 500 Digital Stethoscope. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Eko Devices, Inc. (Oakland, US). The FDA issued a Cleared decision on May 26, 2023, 129 days after receiving the submission on January 17, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K230111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2023 |
| Decision Date | May 26, 2023 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQD - Stethoscope, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1875 |