K023209 is an FDA 510(k) clearance for the INSIGHT MILLENNIUM III. This device is classified as a Electromyograph, Diagnostic (Class II - Special Controls, product code IKN).
Submitted by Fasstech (North Billerica, US). The FDA issued a Cleared decision on October 10, 2003, 379 days after receiving the submission on September 26, 2002.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1375.
| 510(k) Number | K023209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2002 |
| Decision Date | October 10, 2003 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IKN — Electromyograph, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1375 |