Duns Number:551540334
Device Description: Basic Set for AuDX branded SentieroContent:- carrying bag A/N100503- USB cable A/N100089- Basic Set for AuDX branded SentieroContent:- carrying bag A/N100503- USB cable A/N100089- AuDX A/N100098-AU- Headphone HB7/DD45 A/N100306-US- Probe EP-DP PATH long A/N100028-US- FW TEOAE Quick A/N100109-QUICK- FW DPOAE Quick A/N100110-QUICK- FW FMDPOAE A/N100536- FW PTA Class 4 Advanced A/N100653- FW Magic A/N100112- FW Mira PC- Software A/N100116- FW Labelprinter A/N100414- Accessory box combo A/N100261- Power Supply Sentiero US A/N100083-US- User Manual A/N100904-EN-BL
Catalog Number
-
Brand Name
Sentiero Basic AuDX Set
Version/Model Number
100250-BL1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 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
K133012
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
a6340d9a-a04d-4a17-a587-f9d6940666f2
Public Version Date
June 30, 2020
Public Version Number
3
DI Record Publish Date
April 10, 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 |