Duns Number:231959888
Device Description: The zensor software system is a web and PC based tool assisting clinicians in managing pat The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
Catalog Number
-
Brand Name
Zensor+ software
Version/Model Number
PN0811
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151027
Product Code
MHX
Product Code Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Public Device Record Key
0a4d1f5e-1563-4583-b41f-1f913d79503f
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 15, 2018
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 |