K240901 is an FDA 510(k) clearance for the Stethophone. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Sparrow Acoustics, Inc. (Lucasville, CA). The FDA issued a Cleared decision on September 19, 2024, 170 days after receiving the submission on April 2, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K240901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2024 |
| Decision Date | September 19, 2024 |
| Days to Decision | 170 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 |