K964952 is an FDA 510(k) clearance for the VERIDOSE V (FIVE), MODEL NUMBER 37-705. This device is classified as a System, Therapeutic, X-ray (Class II - Special Controls, product code JAD).
Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on July 21, 1997, 223 days after receiving the submission on December 10, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5900.
| 510(k) Number | K964952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1996 |
| Decision Date | July 21, 1997 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAD — System, Therapeutic, X-ray |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5900 |