K210736 is an FDA 510(k) clearance for the doctorgram Stethoscope DES-I. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Gv Concepts (San Jose, US). The FDA issued a Cleared decision on July 27, 2021, 138 days after receiving the submission on March 11, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K210736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2021 |
| Decision Date | July 27, 2021 |
| Days to Decision | 138 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 |