Duns Number:551540334
Device Description: Sentiero Desktop Diagnostic Starter KitContent:1. Sentiero Desktop (Tymp Diagnostic) AN100 Sentiero Desktop Diagnostic Starter KitContent:1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG2. USB data cable AN1004183. Software label printer AN1004144. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally5. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally
Catalog Number
-
Brand Name
Sentiero Desktop Diagnostic
Version/Model Number
100497-SK
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
ETY
Product Code Name
Tester, Auditory Impedance
Public Device Record Key
f7e747f9-7417-43a8-b36d-37ad75eb6d95
Public Version Date
September 29, 2022
Public Version Number
2
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 |