K071899 is an FDA 510(k) clearance for the BIS MODULE FOR ENVOY PATIENT MONITOR. This device is classified as a Index-generating Electroencephalograph Software (Class II - Special Controls, product code OLW).
Submitted by Mennen Medical , Ltd. (Rohovot, IL). The FDA issued a Cleared decision on October 22, 2007, 105 days after receiving the submission on July 9, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User..
| 510(k) Number | K071899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2007 |
| Decision Date | October 22, 2007 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLW — Index-generating Electroencephalograph Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User. |