Duns Number:664020405
Device Description: The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of function The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate
Catalog Number
-
Brand Name
EMAY
Version/Model Number
EMO-40
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2025
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140582
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
1d32aa36-04cc-4a7a-8736-f93734187cd5
Public Version Date
December 03, 2019
Public Version Number
1
DI Record Publish Date
November 25, 2019
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. | 8 |