Duns Number:144683042
Device Description: An electricity (AC-powered) device assembly consisting of a desktop unit, a graphical disp An electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Dopple. Clinical applications include venous/arteria/cardiovascular/cephalic flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis),emboli counting,vasospasm,sah,, and/or blood flow wave form recording.
Catalog Number
TOC1M
Brand Name
toc1m neurovision transcranial doppler
Version/Model Number
TOC1M NEUROVISION
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
K060112
Product Code
IYN
Product Code Name
System, Imaging, Pulsed Doppler, Ultrasonic
Public Device Record Key
e97f3443-ef42-4824-aea6-b8487cc0a371
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 20, 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. | 1 |