K791580 is an FDA 510(k) clearance for the CEREBRAL FUNCTION MONITOR 870. This device is classified as a Amplitude-integrated Electroencephalograph (Class II - Special Controls, product code OMA).
Submitted by Applied Medical Research (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979, 18 days after receiving the submission on August 17, 1979.
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 | K791580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1979 |
| Decision Date | September 04, 1979 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| 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). |