K211779 is an FDA 510(k) clearance for the ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Chip Ideas Electronics S.L. (Burjasot, ES). The FDA issued a Cleared decision on May 26, 2022, 351 days after receiving the submission on June 9, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K211779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2021 |
| Decision Date | May 26, 2022 |
| Days to Decision | 351 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 |