Duns Number:053824652
Device Description: Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability
Catalog Number
-
Brand Name
MES 9000 Static Electromyography Scanner
Version/Model Number
Static EMG Scanner
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
K013399,K013399
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
6efc8710-51c8-4ebe-a837-f087e2b7ce16
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
D792N9150
Quantity per Package
2
Contains DI Package
D792N150MES0
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. | 7 |