K233609 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 Health, Inc. (Emeryville, US). The FDA issued a Cleared decision on March 28, 2024, 136 days after receiving the submission on November 13, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K233609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2023 |
| Decision Date | March 28, 2024 |
| Days to Decision | 136 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 |