Duns Number:962519208
Device Description: Echo-Screen III Pro Hearing Screening Device TEOAE, DPOAE and ABR set
Catalog Number
-
Brand Name
NATUS MEDICAL
Version/Model Number
013506
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 20, 2017
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
K141446
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
041eaa67-5cab-4d40-91f6-3e07a5a528af
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 26, 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 |