K954397 is an FDA 510(k) clearance for the BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Koven Technology, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 29, 1996, 191 days after receiving the submission on September 20, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K954397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 1995 |
| Decision Date | March 29, 1996 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | DPW - Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |