Duns Number:134139174
Device Description: ForeSight Sensor Medium
Catalog Number
FSESM
Brand Name
ForeSight
Version/Model Number
FSESM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
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
K143675,K143675
Product Code
MUD
Product Code Name
Oximeter, Tissue Saturation
Public Device Record Key
d9c147d4-3e8e-48c8-aa02-c9906fcd659b
Public Version Date
May 15, 2020
Public Version Number
1
DI Record Publish Date
May 07, 2020
Package DI Number
50690103208134
Quantity per Package
20
Contains DI Package
00690103208139
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |