K193631 is an FDA 510(k) clearance for the Stethee Pro 1, Stethee Pro Software System. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by M3Dicine Pty , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on October 9, 2020, 287 days after receiving the submission on December 27, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K193631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2019 |
| Decision Date | October 09, 2020 |
| Days to Decision | 287 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 |