Duns Number:101772069
Device Description: The OmniAmp Interface Module is an amplifier interface module used in polysomnogram (PSG) The OmniAmp Interface Module is an amplifier interface module used in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center
Catalog Number
360-8410
Brand Name
OmniPro System
Version/Model Number
OmniPro Interface Module
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050143
Product Code
GWQ
Product Code Name
Full-Montage Standard Electroencephalograph
Public Device Record Key
83e5db3c-2414-4c14-97bc-6c0b42846f6b
Public Version Date
December 17, 2019
Public Version Number
1
DI Record Publish Date
December 09, 2019
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. | 5 |