Duns Number:962519208
Device Description: The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display o The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing disorders.
Catalog Number
580-NAVPR2
Brand Name
Bio-logic
Version/Model Number
Navigator Pro
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K031009,K073626,K083371
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
426ab753-ce0e-44d0-ac9c-91282d1f806e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 22, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |