Duns Number:962519208
Device Description: The ABaer Hearing Screening System performs automated objective hearing screening utilizin The ABaer Hearing Screening System performs automated objective hearing screening utilizing auditory brainstem responses (ABR) and/or otoacoustic emissions (OAE).
Catalog Number
580-ABAER2
Brand Name
Bio-logic
Version/Model Number
ABaer
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
K112247
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
9fdabf03-2b54-4205-bf77-e0d73dc252f0
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 |