Duns Number:369960000
Device Description: ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyo ME6000 is a portable telemetry and data logger in measurement and monitoring of electromyography (EMG) and other physiological signals.
Catalog Number
-
Brand Name
ME6000
Version/Model Number
ME6000 4ch WLAN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
K963202
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
39584104-519e-43a9-8d84-15d9e9554f36
Public Version Date
December 31, 2021
Public Version Number
6
DI Record Publish Date
September 22, 2016
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. | 21 |