Duns Number:306633756
Catalog Number
-
Brand Name
GN Otometrics A/S
Version/Model Number
MADSEN AccuScreen, DP
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
K122067
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
c3d5f0ae-2c7b-4f59-96da-24653510fc1b
Public Version Date
December 03, 2020
Public Version Number
3
DI Record Publish Date
November 06, 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 | 32 |
2 | A medical device with a moderate to high risk that requires special controls. | 398 |