Duns Number:134990550
Device Description: SpO2 sensors are electro-optical sensors that function without skin penetration, electrica SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the Oximeter. The sensor contains three optical components, (LED) that serves as light sources and one photodiode that acts as light detector. The optical components are housed in adhesive film/rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated by a connector as specified by the different make/ manufacturer of the pulse Oximeter, with an optional adapter cable for compatible models.
Catalog Number
-
Brand Name
Adhesive Disposable sensor with Micro Foam Tape - Neonatal
Version/Model Number
POX020-980
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
Yes
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
K041964,K041964
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
ef2963cd-0635-4593-9e7d-4fc377ebe09e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2016
Package DI Number
POX0209802
Quantity per Package
24
Contains DI Package
B425POX0209802
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 203 |