Duns Number:559784736
Device Description: Program Baha Sound Processors
Catalog Number
P803255
Brand Name
Cochlear™ Baha® Fitting Software
Version/Model Number
P803255
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
K090720
Product Code
LXB
Product Code Name
Hearing aid, bone conduction
Public Device Record Key
ea01d198-53f0-425f-87df-359df7218f88
Public Version Date
May 25, 2021
Public Version Number
2
DI Record Publish Date
October 21, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 276 |