Duns Number:064063916
Device Description: The OX-550AP Pediatric Finger Pulse Oximeter will display oxygen saturation (Spo2) and pul The OX-550AP Pediatric Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It is specifically designed for small fingers allowing for fast accurate oximetry results with pediatric users. It displays the perfusion index (PI) to help in selecting the best finger for testing.
Catalog Number
OX550AP
Brand Name
MTS
Version/Model Number
OX-550AP
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
4394f19e-8aad-4b63-9228-06c763bfa1a7
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
November 13, 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 |