K050601 is an FDA 510(k) clearance for the SMARTDOP 45 VASCULAR DOPPLER. 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 April 15, 2005, 37 days after receiving the submission on March 9, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K050601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2005 |
| Decision Date | April 15, 2005 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | DPW - Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |