Duns Number:314101143
Device Description: IntelliVue EEG Module M1027B for use with IntelliVue Patient Monitors MP40-MP90 and MX500- 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.
Catalog Number
866078
Brand Name
PHILIPS IntelliVue EEG Module
Version/Model Number
IntelliVue EEG Module
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSJ
Product Code Name
ALARM, BLOOD-PRESSURE
Public Device Record Key
0a3399d3-6cc1-4065-9494-2994d11c6f98
Public Version Date
August 15, 2022
Public Version Number
6
DI Record Publish Date
October 06, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |