K990793 is an FDA 510(k) clearance for the ACCUGUIDE MUSCLE INJECTION MONITOR. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on October 22, 1999, 226 days after receiving the submission on March 10, 1999.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K990793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1999 |
| Decision Date | October 22, 1999 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXZ - Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |