Duns Number:962519208
Device Description: The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in the earcanal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear as a result of normal peripheral hearing processes. The AuDX Pro device performs both transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening and diagnostic test environments.
Catalog Number
580-AXPBOX-010
Brand Name
Bio-Logic AudX
Version/Model Number
580-AXPBOX-010
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122496
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
445524c8-d40c-429a-a82e-d9f1dcbf8e1f
Public Version Date
January 17, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2018
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 |