Duns Number:058614483
Device Description: BIS LoC 4 Channel Refurbished, Software Version 1.15. For use with Philips Patient Monitor BIS LoC 4 Channel Refurbished, Software Version 1.15. For use with Philips Patient Monitors
Catalog Number
-
Brand Name
BIS
Version/Model Number
186-1030-PH
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
K072286
Product Code
OLW
Product Code Name
Index-generating electroencephalograph software
Public Device Record Key
953b2a70-facf-456a-8eba-d0bc98e6fa54
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
August 15, 2017
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |