K050097 is an FDA 510(k) clearance for the TECHNO-SCOPE VISUAL STETHOSCOPE. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Techtrade, LLC (Potomac, US). The FDA issued a Cleared decision on September 30, 2005, 259 days after receiving the submission on January 14, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K050097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2005 |
| Decision Date | September 30, 2005 |
| Days to Decision | 259 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 |