Duns Number:671280238
Device Description: Head Phones Slim is part of NordicNeuroLab’s Audio System.The AudioSystem allows auditory Head Phones Slim is part of NordicNeuroLab’s Audio System.The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. A communication console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.The Head Phone Slim is designed specifically for use in the MR environment, and are compatible with MR system up to 3T.
Catalog Number
-
Brand Name
HeadPhones Slim
Version/Model Number
HPS 1.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 06, 2018
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092253
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
092c99ae-b7a8-4ad9-be93-20d067b91df4
Public Version Date
June 02, 2020
Public Version Number
6
DI Record Publish Date
October 24, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |