Duns Number:006385173
Device Description: The Nox T3 is an easy to use Pulse Oximeter that utilizes cloud technology for convenient The Nox T3 is an easy to use Pulse Oximeter that utilizes cloud technology for convenient and prompt readings. The Nox T3 is designed to assess the functioning of the airway using SPO2 and variations in heart rate to measure how well the airway is functioning. The Oximeter measures the blood oxygen level and heart rate then transmits the data to the Galaxy Tablet for storage and processing
Catalog Number
-
Brand Name
Pulse Oximeter
Version/Model Number
20012120
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2019
Issuing Agency
In HIBCC
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
K082641
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
b6464b8e-5e54-465c-981d-9d8c7ec6cfdd
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
May 01, 2017
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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 293 |
| U | Unclassified | 1 |