Duns Number:519969810
Device Description: The DataLOG is the latest in data acquisition technology developed to meet the needs of re The DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection and monitoring in human performance, sports science, medical research, industrial ergonomics, gait laboratories, and educational settings. Includes: 8 channel data acquisition unit, Bluetooth adapter, 6 x Micro SD cards, Card reader, Management Software, instrument caseThis product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
Catalog Number
MWX8 DataLOG - plastic connectors
Brand Name
DataLOG MWX8
Version/Model Number
MWX8
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKK
Product Code Name
System, Isokinetic Testing And Evaluation
Public Device Record Key
df5a2e94-b1f4-4f8c-86d5-4eef4fa2044d
Public Version Date
March 05, 2020
Public Version Number
2
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 |