K080217 is an FDA 510(k) clearance for the COMPONENT NEUROMONITORING SYSTEM. This device is classified as a Amplitude-integrated Electroencephalograph (Class II - Special Controls, product code OMA).
Submitted by Moberg Research, Inc. (Ambler, US). The FDA issued a Cleared decision on November 5, 2008, 281 days after receiving the submission on January 29, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner)..
| 510(k) Number | K080217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2008 |
| Decision Date | November 05, 2008 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OMA - Amplitude-integrated Electroencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner). |