Duns Number:551540334
Device Description: content:- carrying bag A/N100503- USB Cable A/N100418- AuDX PRO Flex A/N100434-AUPF- Probe content:- carrying bag A/N100503- USB Cable A/N100418- AuDX PRO Flex A/N100434-AUPF- Probe EP-TY A/N100188-US- Insert Earphone Bio- Logic A/N100860-BL- Bone Conductor B71 A/N100344- Gooseneck Microphone A/N100779- FW Reflex & Tymp Class1 A/N100561- FW TEOAE A/N100109- FW DPOAE A/N100110- FW FMDPOAE A/N100536- FW DPHiRES A/N100537- FW Mira PC- Software A/N100116- FW PTA3 A/N100114- FW High Frequency A/N100454- FW Magic A/N100112- FW Labelprinter A/N100414- Accessory Box Combo A/N100261- Power Supply Senti/Sentiero Desktop US A/N100524- User Manual A/N100904-EN-BL- Test Cavity Tymp A/N100549
Catalog Number
-
Brand Name
Sentiero Desktop AuDX PRO Flex Set
Version/Model Number
100497-BLP1
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
ETY
Product Code Name
Tester, Auditory Impedance
Public Device Record Key
258e865e-32fc-49cc-b632-4cd1103543bb
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 |