Duns Number:064063916
Device Description: The OX-400A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR The OX-400A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It also displays the perfusion index (PI) to help in selecting the best site for testing, providing fast and accurate oximetry measurements.
Catalog Number
OX400A
Brand Name
MTS
Version/Model Number
OX-400A
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063641
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
78d978a6-ee8d-4084-a7f2-9703976ded75
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
November 09, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |