Duns Number:962519208
Device Description: The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.
Catalog Number
023482R
Brand Name
Echo-Screen III Pro
Version/Model Number
EchoScreen III Refurbished, ABR with barcode
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
K141446
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
1cbc2b64-52e0-47da-8daa-caeed7d3aafc
Public Version Date
February 28, 2020
Public Version Number
1
DI Record Publish Date
February 20, 2020
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 |