Duns Number:643212926
Device Description: The Neuro-Audio system is indicated for use in the recording and analysis of human physiol The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation, documentation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA).The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories.The patient group includes all ages and genders.
Catalog Number
-
Brand Name
Neuro-Audio
Version/Model Number
Neuro-Audio
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
K141524
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
e2a1042d-1fc6-4e93-bc47-6f029fcffdb7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |