K012304 is an FDA 510(k) clearance for the ADC 656 ELECTRONIC STETHOSCOPE. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by American Diagnostic Corp. (Hauppauge, US). The FDA issued a Cleared decision on November 1, 2001, 104 days after receiving the submission on July 20, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K012304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2001 |
| Decision Date | November 01, 2001 |
| Days to Decision | 104 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 |