K780368 is an FDA 510(k) clearance for the MODUMED MUGX. This device is classified as a System, Tomographic, Nuclear (Class II - Special Controls, product code JWM).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on March 14, 1978, 7 days after receiving the submission on March 7, 1978.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1310.
| 510(k) Number | K780368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1978 |
| Decision Date | March 14, 1978 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JWM — System, Tomographic, Nuclear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1310 |