Duns Number:643212926
Device Description: The Neurosoft TMS system is indicated for the treatment of Major Depressive Disorder in a The Neurosoft TMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
Catalog Number
-
Brand Name
Neurosoft
Version/Model Number
TMS
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160309
Product Code
OBP
Product Code Name
Transcranial Magnetic Stimulator
Public Device Record Key
d599e220-8dbf-4a9d-ad10-85624d0a03fe
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
June 05, 2017
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. | 13 |