Duns Number:519969810
Device Description: The DataLITE Management Software allows the user to set up the DataLITE communications wit The DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software.Software is available in English, Chinese, and Japanese.
Catalog Number
-
Brand Name
DataLITE Management Software (Version 10)
Version/Model Number
510xx-100
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
a0ce0938-495b-4edc-a3de-3031435e151a
Public Version Date
September 10, 2018
Public Version Number
1
DI Record Publish Date
August 10, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |