Duns Number:551540334
Device Description: Sentiero Screening2 TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data Sentiero Screening2 TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Probe EP-DP Path long AN100028-US6. TEOAE Quick Software AN100109-Quick7. Software label printer AN1004148. Accessory box Sentiero PT-S AN1009029. Power supply Sentiero US AN101013+AN100993-USA
Catalog Number
-
Brand Name
Sentiero Screening2
Version/Model Number
100250-SC-T
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
K133012
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
2ca546e8-1b43-43ba-a39a-92e031ae1983
Public Version Date
July 06, 2020
Public Version Number
1
DI Record Publish Date
June 27, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |