K905111 is an FDA 510(k) clearance for the DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Eigen (Nevada City, US). The FDA issued a Cleared decision on January 25, 1991, 73 days after receiving the submission on November 13, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K905111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1990 |
| Decision Date | January 25, 1991 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |