K031931 is an FDA 510(k) clearance for the ECHO SOUNDER EX-101EX 8 MHZ. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Koven Technology, Inc. (Houston, US). The FDA issued a Cleared decision on February 13, 2004, 235 days after receiving the submission on June 23, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K031931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2003 |
| Decision Date | February 13, 2004 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPW - Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |