IntelliVue EEG Module M1027B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The module provides continuous real-time monitoring of the Electroencephalogram (EEG) and…
IntelliVue EEG Module M1027B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. The module provides continuous real-time monitoring of the Electroencephalogram (EEG) and produces four channels of EEG waveforms with Compressed Spectral Array (CSA) analysis.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for EEG Module | Listed by | Philips Medizin Systeme Böblingen GmbH, Germany |
| FDA product code | DSJ |
| Device type | Alarm, Blood-Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1100 |
| Record published | 2016-10-06 |
| Record revised | 2023-05-05 (version 7) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment atmospheric pressure 57 to 106 KiloPascal; Storage environment humidity 15 to 90 % RH |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.