Duns Number:064063916
Device Description: The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxygen satura The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxygen saturation (Spo2) and pulse rate (PR). It is motion tolerant and can be used during exercise and other daily activities.
Catalog Number
OX610A
Brand Name
MTS
Version/Model Number
OX-610A
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
OCH
Product Code Name
Oximeter, Infrared, Sporting, Aviation
Public Device Record Key
0b0f5eed-eebd-40b8-8c71-bbc3c2c1220b
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 |