K972419 is an FDA 510(k) clearance for the TOENNIES NEUROSCREEN SYSTEM. This device is classified as a Electromyograph, Diagnostic (Class II - Special Controls, product code IKN).
Submitted by Erich Jaeger, Inc. (Hoechberg, Germany, DE). The FDA issued a Cleared decision on April 30, 1998, 307 days after receiving the submission on June 27, 1997.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1375.
| 510(k) Number | K972419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1997 |
| Decision Date | April 30, 1998 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | IKN — Electromyograph, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1375 |