Duns Number:533070236
Device Description: 10 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect r 10 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the FALCON system for noninvasive measurements of blood flow velocities in arteries and veins
Catalog Number
-
Brand Name
10 MHz probe
Version/Model Number
10 MHz probe
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 19, 2020
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
K111416
Product Code
JOP
Product Code Name
Transducer, Ultrasonic
Public Device Record Key
256c2a16-675a-4578-b48d-ecfbf07b332a
Public Version Date
June 29, 2020
Public Version Number
1
DI Record Publish Date
June 19, 2020
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 |