Duns Number:178180246
Device Description: Includes 1 Evolution Handle, I-Scan Software CD with 2 K-Scan Sensor maps, Sensor Carrying Includes 1 Evolution Handle, I-Scan Software CD with 2 K-Scan Sensor maps, Sensor Carrying Case, System Carrying Case, and System Manual. 1 Day of Training (USA Only). Sensor selection: Choice of up to 5 sensors corresponding to the maps chosen above (value up to $1,000)
Catalog Number
KE1
Brand Name
K-Scan Evolution
Version/Model Number
K-Scan Joint Pressure Measurement System
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"
-
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
JFC
Product Code Name
System, Pressure Measurement, Intermittent
Public Device Record Key
fe535bed-2702-41de-9b7d-828b2713bdb9
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
November 03, 2020
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 | 199 |