Duns Number:533070236
Device Description: 2 MHz monitoring probe is an ultrasonic transducer which generate acoustic signals and als 2 MHz monitoring probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the Dolphin system for noninvasive measurements of blood flow velocities in arteries and veins
Catalog Number
-
Brand Name
2 MHz monitoring
Version/Model Number
2 MHz monitoring , 5 meter cable
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 14, 2019
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
K191023
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
15ac0db9-ef49-4e29-b094-1c9e3dab3330
Public Version Date
June 17, 2019
Public Version Number
1
DI Record Publish Date
June 07, 2019
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 |