Duns Number:618825723
Device Description: KenTeK FINGER PULSE OXIMETER WITH OLED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND P KenTeK FINGER PULSE OXIMETER WITH OLED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE RATE, PR WAVEFORM DISPLAY, LOW BATTERY INDICATOR, AUTOMATIC POWER OFF, FOUR DIRECTIONS DISPLAY.
Catalog Number
KT-2000
Brand Name
KenTeK
Version/Model Number
KT-2000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K141105
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
16d242dd-963d-4ea0-b49e-a8825dd89945
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
November 18, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |