Duns Number:533070236
Device Description: The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assis The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity
Catalog Number
-
Brand Name
Dolphin/XF Robot Accessory
Version/Model Number
Dolphin/XF Robot Accessory
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 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
K202742
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
d9e0e5ac-7e52-4246-a2e6-ff04c2d57cab
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
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. | 26 |