K042208 is an FDA 510(k) clearance for the ISIS MER SYSTEM/ELEKTA MER SYSTEM. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Inomed Medizintechnik GmbH (Stockholm, DE). The FDA issued a Cleared decision on March 18, 2005, 214 days after receiving the submission on August 16, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K042208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2004 |
| Decision Date | March 18, 2005 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL - Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |