K052283 is an FDA 510(k) clearance for the HEART STG SYSTEM AND SOFTWARE. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Stethographics, Inc. (Boston, US). The FDA issued a Cleared decision on December 23, 2005, 123 days after receiving the submission on August 22, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K052283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2005 |
| Decision Date | December 23, 2005 |
| Days to Decision | 123 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 |