K984401 is an FDA 510(k) clearance for the NEUROMAG VECTORVIEW. This device is classified as a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II - Special Controls, product code OLX).
Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on December 30, 1998, 21 days after receiving the submission on December 9, 1998.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization.
| 510(k) Number | K984401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1998 |
| Decision Date | December 30, 1998 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization |