K973368 is an FDA 510(k) clearance for the STRAIT'MAP OPTION. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 17, 1997, 39 days after receiving the submission on September 8, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K973368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1997 |
| Decision Date | October 17, 1997 |
| Days to Decision | 39 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 |