K963274 is an FDA 510(k) clearance for the V-LINK 3.2 FOR WINDOWS. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Koven Technology, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 31, 1996, 72 days after receiving the submission on August 20, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K963274 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1996 |
| Decision Date | October 31, 1996 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |