K943355 is an FDA 510(k) clearance for the GEMNET. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on November 7, 1994, 118 days after receiving the submission on July 12, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K943355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 1994 |
| Decision Date | November 07, 1994 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI - System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |