K221805 is an FDA 510(k) clearance for the AccurSound Electronic Stethoscope AS-101. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Heroic Faith International , Ltd. (Taipei City, TW). The FDA issued a Cleared decision on March 23, 2023, 274 days after receiving the submission on June 22, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K221805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2022 |
| Decision Date | March 23, 2023 |
| Days to Decision | 274 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 |