Duns Number:551540334
Device Description: Senti Audiometry (Class 4 Advanced) Set Content:1. Case AN1005032. Inlay Sentiero AN100677 Senti Audiometry (Class 4 Advanced) Set Content:1. Case AN1005032. Inlay Sentiero AN1006773. Senti device with touchscreen AN1000974. FW Labelprinter AN1004145. Pure Tone Audiometer Class 4A AN1006536. Headphone HDA-280 AN1001177. Power supply AN1000838. USB data cable AN100089
Catalog Number
-
Brand Name
Senti Set 1
Version/Model Number
100330
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2020
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
-
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
aa3623ae-6cff-4337-9d32-7a134a387624
Public Version Date
January 21, 2020
Public Version Number
2
DI Record Publish Date
May 14, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |