K191667 is an FDA 510(k) clearance for the Electronic Stethoscope. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Hefei Mintti Medical Technology Co., Ltd. China (Hefei, CN). The FDA issued a Cleared decision on December 18, 2019, 180 days after receiving the submission on June 21, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K191667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2019 |
| Decision Date | December 18, 2019 |
| Days to Decision | 180 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 |